Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, & Cosmetic Act (BPCA and PREA, respectively), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under PREA.
Total Number of Products Studied under BPCA = 74
Total Number of Products assessed under PREA = 454
Total Number of Products Studied or assessed under Both = 75
| Drug Sponsor | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Abametapir - Xeglyze | HATCHTECH PTY LTD |
Medical (PDF - 4 MB) Addendum (PDF - 78 KB) CDTL (PDF - 3 MB) Resubmission (PDF - 77 KB) DD (PDF - 2 MB) |
Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 207 KB) | PREA |
| Abacavir and Lamivudine - Epzicom | ViiV Healthcare Company | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 158 KB) | Statistical (PDF - 693 KB) | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq | ViiV Healthcare Company | Medical (PDF - 443 KB) | Clinical pharmacology (PDF - 128 KB) | None | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq |
ViiV Healthcare Company c/o GlaxoSmithKline |
Medical (PDF - 389 KB) CDTL (PDF - 798 KB) |
Clinical pharmacology (PDF - 128 KB) | None | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq PD | ViiV Healthcare Company | CDTL (PDF - 758 KB) | Clinical pharmacology (PDF - 3 MB) | None | BOTH |
| Abacavir sulfate - Ziagen | ViiV Healthcare Company | Medical (PDF - 4.2 M B) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 5 MB) | PREA |
| Abatacept - Orencia | Bristol-Myers Squibb Company |
Medical (PDF - 259 KB) Medical Addendum (PDF - 469 KB) |
Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 269 KB) |
None | BOTH |
| Abatacept - Orencia | Bristol-Myers Squibb Company | Medical (PDF - 4 MB) | None | None | BPCA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | CDTL Review (PDF - 2 MB) Medical (PDF - 3 MB) |
None | Statistical (PDF - 2 MB) | PREA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | Medical (PDF - 1 MB) | None | Statistical (PDF - 857 KB) | PREA |
| Abrocitinib - Cibinqo |
Pfizer Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Abrocitinib - Cibinqo | Pfizer Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Acetaminophen - Ofirmev | MallInc.krodt, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 378 KB) | BOTH |
| Acetylcysteine - Legubeti | Galephar Pharmaceutical Research Inc. |
Unireview (PDF - 6 MB) Unireview CR (PDF - 10 MB) |
None | None | PREA |
| Acyclovir 5%, hydrocortisone 1% - Xerese | Valeant International Bermuda | Medical (PDF - 885 KB) | None | None | PREA |
| Adalimumab-adaz - Hyrimoz |
Sandoz Inc. |
Medical (PDF - 2 MB) CDTL Review (PDF - 300 MB) |
None | None | PREA |
|
Adalimumab-adaz - Hyrimoz |
Sandoz Inc. |
CDTL Review (PDF - 342 KB) |
None | None | PREA |
| Adalimumab-adaz - Hyrimoz | Sandoz Inc. | CDTL Review (PDF - 34 KB) | None | None | PREA |
| Adalimumab-adbm - Cyltezo | Boehringer Ingelheim | Medical (PDF - 826 KB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | CDTL (PDF - 34 KB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | CDTL (PDF - 34 KB) | None | None | PREA |
| Adalimumab-aqvh - Yusimry | Coherus BioSciences, Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Adalimumab-aqvh - Yusimry | Coherus BioSciences, Inc | CDTL Review (PDF - 342 KB) | Clinical pharmacology (PDF - 22 KB) | None | PREA |
| Adalimumab-atto - Amjevita | Amgen Inc. |
CDTL Review (PDF - 4.3 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 416 KB) Statistical (PDF - 363 KB) Statistical (PDF - 717 KB) |
PREA |
| Adalimumab-aaty - Yuflyma | Celltrion, Inc. | CDTL - DD (PDF - 356 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Adalimumab-atto - Amjevita | Amgen, Inc | CDTL (PDF - 580 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen, Inc | Medical (PDF - 532 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita |
Amgen, Inc | Medical (PDF - 532 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen Inc. | Medical (PDF - 25 KB) | None | None | PREA |
| Adalimumab-bwwd - Hadlima | Samsung Bioepis Co., Ltd. | Medical (PDF - 34 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Adalimumab-bwwd - Hadlima | Samsung Bioepis Co., Ltd. | Medical (PDF - 34 KB) | None | None | PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Adalimumab-fkjp - Hulio |
Mylan Pharmaceuticals Inc. | Medical (PDF - 580 KB) | None | None | PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | CDTL (PDF - 24 KB) | None | None | RPEA |
| Adalimumab - Humira | AbbVie,Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Adalimumab-aacf - Idacio | Fresenius Kabi USA, LLC | Medical (PDF - 20 MB) | None | None | PREA |
| Adalimumab-aacf - Idacio | Fresenius Kabi USA, LLC | Medical (PDF - 20 MB) | None | None | PREA |
| Adapalene and benzoyl peroxide - Epiduo | Galderma Laboratories, LP | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -124 KB) | Statistical (PDF - 577 KB) | PREA |
| Adapalene and benzoyl peroxide - Epiduo Forte | Galderma Research and Development LLC | Medical (PDF - 6.2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
|
Afatini - Gilotrif |
Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | BPCA |
| Aflibercept - Eylea |
Regeneron Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 5 MB) | BPCA |
| Anidulafungin - Eraxis | Vicuron Holdings LLC, a subsidiary of Pfizer Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Albuterol and Budesonide - Airsupra | Bond Avillion 2 Development LP | Medical (PDF - 12 MB) | None | None | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Pharmaceutical Products R. & D., Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 859 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Alirocumab - Praluent | Regeneron Pharmaceuticals, Inc | Medical (PDF - 859 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Aliskiren - Tekturna | Noden Pharma DAC | CDTL (PDF - 310 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 442 KB) | BOTH |
| Alogliptin - Nesina | Takeda Pharmaceuticals U.S.A., Inc | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 937 KB) | Statistical (PDF - 536 KB) | PREA |
| Alogliptin and metformin - Kazano | Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 937 KB) | Statistical (PDF - 536 KB) | PREA |
|
Amlodipine benzoate - Katerzia |
Silvergate Pharmaceuticals, Inc | Medical (PDF - 46 KB) | Clinical pharmacology (PDF - 337 KB) | None |
PREA |
| Amphetamine - Adzenys ER | Neos Therapeutics, Inc. | Medical (PDF - 1.9 MB) | Clinical pharmacology (PDF - 4 KB) | None | PREA |
| Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT | Neos Therapeutics, Inc. | Medical (PDF - 470 KB) | Clinical pharmacology (PDF -3 MB) | None | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma | Medical (PDF - 1.8 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 767 KB) | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma |
Medical (PDF - 848 KB) CDTL Review (PDF - 1 MB) |
None | None | PREA |
|
Amphetamine sulfate - Evekeo |
Arbor Pharmaceuticals, LLC |
Medical (PDF - 1 MB) Medical (PDF - 155 KB) |
Clinical pharmacology (PDF - 9 KB) Clinical pharmacology memo (PDF - 9 KB) |
Statistical (PDF - 532 KB) | PREA |
| Apremilast - Otezla | Amgen, Inc | Medical (PDF - 7 MB) | None | None | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 6 MB) Medical Addendum (PDF -1 MB) Medical DD memo (PDF - 3 MB) |
Clinical pharmacology (PDF - 5 MB) Clinical pharmacology addendum (PDF - 424 KB) |
Statistical (PDF - 1 MB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 553 KB) | Clinical pharmacology (PDF - 5 MB) Addendum (PDF -105 KB) |
Statistical (PDF - 1 MB) | PREA |
| Aripiprazole - Abilify | Otsuka | Medical (PDF - 2.4MB) | None | Statistical (PDF - 409 KB) | PREA |
| Asenapine - Saphris | Forest Laboratories, Inc. | Medical (PDF - 5 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 3 MB) | BOTH |
| Asparaginase erwinia chrysanthemi (recombinant)- rywn - Rylaze | Jazz Pharmaceuticals Ireland Limited | Medical (PDF - 4 MB) | None | None | PREA |
| Atazanavir and cobicistat - Evotaz | Bristol-Myers Squibb Company | CDTL (PDF - 402 KB) | Clinical pharmacology (PDF -1 MB) | None | PREA |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 14 MB) | Clinical pharmacology (PDF -1 MB) | Statistical (PDF - 2 MB) | BOTH |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 4 MB) | BOTH |
|
Atezolizumab - TECENTRIQ |
Genentech, Inc. | Medical (PDF - 1 MB) | None | None | BPCA |
|
Atezolizumab - Tecentriq |
Genentech, Inc. | Medical (PDF - 3 MB) | None | None | BPCA |
| Atorvastatin calcium - Atorvaliq | CMP Development LLC | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
|
Atropine-pralidoxime - DueDote |
Meridian Medical Technologies, Inc. |
CDTL (PDF - 402 KB) Medical (PDF - 886 KB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Atropine Sulfate - Isopto Atropine 1% | Alcon Research, Ltd. | Medical (PDF - 663KB) | Clinical pharmacology (PDF - 480KB) | Statistical (PDF - 230KB) | PREA |
| Atropine Sulfate Ophthalmic Solution | Akorn, Inc. | Medical (PDF - 1.2 MB) | Clinical pharmacology (PDF - 1MB) | Statistical (PDF - 287KB) | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals | Clinical (PDF -1 .4MB) | None | Statistical (PDF -473 KB | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals Inc. | Medical (PDF - 2MB) | None | None | BOTH |
| Azelastine hydrochloride and Fluticasone propionate - Dymista | Meda Pharmaceuticals, Inc. | Medical (PDF - 2.9MB) | None | Statistical (PDF -2.1MB) | BOTH |
| Baclofen - Fleqsuvy | Azurity Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 367 KB) | None | PREA |
| Baclofen - Lyvispah | Saol Therapeutics Research Limited | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 448 KB) | None | PREA |
|
Baloxavir marboxil - Xofluza |
Shionogi, Incorporated
|
CDTL (PDF - 869 KB) Medical (PDF - 414 KB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 2 MB) | PREA |
| Baloxavir marboxil - Xofluza | Genentech, Incorporated |
CDTL (PDF - 853 KB) Medical (PDF - 6 MB KB) |
Clinical pharmacology (PDF - 420 KB) | None | PREA |
| Baloxavir marboxil - Xofluza | Genentech, Incorporated | Medical (PDF - 11 MB) | None | None | PREA |
| Barium sulfate - E-Z-HD | Bracco Diagnostics Inc. | Medical (PDF - 2.4MB) | Clinical pharmacology (PDF -642KB) | Statistical (PDF -988KB) | PREA |
| Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE | Bracco Diagnostics | Medical (PDF - 2.4MB) | Clinical pharmacology (PDF - 702 KB) | Statistical (PDF -1 MB) | PREA |
| Barium sulfate - Varibar Pudding | Bracco Diagnostics, Inc. | Medical (PDF - 1MB) | None | None | PREA |
| Barium sulfate - Liquid E-Z-Paque | Bracco Diagnostics, Inc. | DD Summary Review (PDF - 233 KB) | None | None | PREA |
| Beclomethasone dipropionate - Qnasl | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF -959 KB) | PREA |
| Belimumab - Benlysta | GlaxoSmithKline (GSK) LLC | Medical (PDF - 5 MB) | None | None | PREA |
|
Belumosudil - Rezurock
|
Kadmon Pharmaceuticals, LLC | Medical (PDF - 7MB) | None | None | PREA |
| Belimumab - Benlysta | Human Genome Sciences | Medical (PDF - 6 MB) | None | None | PREA |
| Belimumab - Benlysta | GlaxoSmithKline LLC | Medical (PDF - 7 MB) | None | None | PREA |
| Benralizumab - Fasenra | AstraZeneca AB | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 2 MB) | PREA |
| Benralizumab - Fasenra | AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP |
Medical (PDF - 7 MB) Unireview (PDF - 11 KB) |
None | None | PREA |
| Berdazimer - Zelsuvmi | LNHC, Inc. | Medical (PDF - 12 MB) | None | None | PREA |
| Bezlotoxumab - Zinplava | Merck Sharp & Dohme Corp. | Medical (PDF - 2 MB) | None | None | BOTH |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. |
CDTL (PDF - 157 KB) CDTL 1 (PDF - 2 MB) |
Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. | CDTL (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Bimatoprost ophthalmic solution, 0.03% - Latisse | Allergan, Inc. | DD Summary Review (PDF - 966KB) CDTL Review (PDF - 3 MB) Medical (PDF - 2 MB) |
None | Statistical (PDF -946KB) Statistical Addendum (PDF - 127KB) |
PREA |
|
Blinatumomab - Blincyto
|
Amgen, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF -1 MB) | Statistical (PDF -374 KB) | BPCA |
| Blinatumomab - Blincyto | Amgen, Inc. | Medical (PDF - 9 MB) |
None
|
None | BPCA |
| Bortezomib - Velcade | Millennium Pharmaceuticals, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF -1 MB) | Statistical (PDF - 374 KB) | BPCA |
| Bosutinib - BOSULIF | PF Prism C.V | Medical (PDF - 10 MB) | None | None | BPCA |
| Budesonide - Entocort EC | Elan Pharma International | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | PREA |
| Brentuximab vedotin - Adcetris | Seagen Inc. | Medical (PDF - 1 MB) | None | None | BPCA |
|
Brexanolone - Zulresso |
Sage Therapeutics, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Brexpiprazole - Rexulti |
Otsuka Pharmaceutical Company, Ltd. | Medical (PDF - 4 MB) | None | None | PREA |
| Brimonidine tartrate - Lumify | Bausch + Lomb | CDTL Review (PDF - 3 MB) Medical (PDF - 556 KB) |
Clinical pharmacology (PDF - 51 KB) | Statistical (PDF - 219 KB) | PREA |
| Brivaracetam - Briviact | UCB, Inc. |
CDTL Review (PDF - 297 KB) Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) | None |
PREA
|
| Brivaracetam - Briviact | UCB, Inc. | Medical (PDF - 74 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Budesonide/formoterol fumarate dehydrate - Symbicort | AstraZeneca Pharmaceuticals, LP | Medical (PDF - 3.4 MB) | Clinical pharmacology (PDF - 1.2 MB) | Statistical (PDF - 2.5 MB) | BOTH |
| Bupivacaine - Exparel | Pacira Pharmaceuticals, Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Buprenorphine - Butrans | Purdue Pharma L.P. | Medical (PDF - 4.1 MB) | Clinical pharmacology (PDF - 1.5 MB) | None | PREA |
| Cabazitaxel - Jevtana | Sanofi-Aventis U.S., L.L.C. | Medical (PDF - 1.5 MB) | Clinical pharmacology (PDF - 1.2 MB) | None | BPCA |
|
Cabotegravir - Apretude |
ViiV Healthcare Company | Medical (PDF - 8 MB) | None | None | PREA |
| Cabotegravir-rilpivirine - Cabenuva |
ViiV Healthcare Company | Medical (PDF - 35 KB) |
Clinical pharmacology (PDF - 1 MB) Clinical pharmacology Addendum (PDF - 229 KB) |
None | PREA |
| Cabotegravir - Vocabria | ViiV Healthcare Company |
CDTL (PDF - 1 MB) Medical (PDF - 525 KB) |
Clinical pharmacology (PDF - 2 MB) Addendum (PDF - 115 KB) |
None | PREA |
| Calcipotriene - SORILUX Foam | Mayne Pharma LLC | Medical (PDF - 525 KB) | None | None | PREA |
| Calcipotriene - SORILUX | Mayne Pharma LLC | Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 1.2 MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF -5.6MB) | Clinical pharmacology (PDF -2.4MB) | Statistical (PDF -564 KB) | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S c/o LEO Pharma, Inc. | Medical (PDF - 3.7MB) | Clinical pharmacology (PDF -2.7MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF - 775 KB) | Clinical pharmacology (PDF - 528 KB) | None | PREA |
| Calcipotriene and betamethasone - Enstilar | LEO Pharma A/S | Medical (PDF - 775 KB) | N | None | BOTH |
| Calcium Gluconate injection - Calcium Gluconate Injection | Fresenius Kabi USA, LLC |
Medical (PDF - 4 MB) Medical CTDL (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Calcitriol - Vectical |
Galderma Laboratories, L.P. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Cantharidin - Ycanth | Verrica Pharmaceuticals Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Capecitabine - Xeloda | Hoffmann-La Roche, Inc. | Medical (PDF - 4MB) | Clinical pharmacology (PDF - 1MB) | Statistical (PDF -610 KB) | BPCA |
| Carbinoxamine maleate - Karbinal ER | Tris Pharma, Inc. | Medical (PDF - 1.4MB) | Clinical pharmacology (PDF - 500 KB) | None | PREA |
| Cefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® Container | B. Braun Medical Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Cefazolin in Dextrose Injection - Cefazolin in Dextrose Injection Sponsor NEW |
Baxter Healthcare Corporation | Medical (PDF - 435 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Ceftaroline fosamil - Teflaro | Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC | Medical (PDF - 11 MB) Medical CTDL (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -1 MB) | PREA |
| Ceftaroline fosamil - Teflaro | Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Ceftazidime and Avibactam - Avycaz | Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Ceftazidime and avibactam - Avycaz | Allergan Sales, LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftazidime and avibactam - Avyca | AbbVie, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftobiprole medocaril sodium for injection - Zevtera | Basilea Pharmaceutica International, Ltd., Allschwil | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftolozane and tazobactam - Zerbaxa | Cubist Pharmaceuticals, LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Certolizumab pegol - Cimzia | UCB, Inc | Medical (PDF - 4 MB) | None | None | PREA |
| Cetirizine ophthalmic solution - Zerviate | Nicox Ophthalmics, Inc. |
Medical Resubmission (PDF - 231 KB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 279 KB) | Statistical (PDF - 580 KB) | BOTH |
| Cetirizine hydrochloride - Quzyttir | JDP Therapeutics Inc | Medical (PDF - 2 MB) | None | None | PREA |
| Ciclesonide - Zetonna | Takeda GmbH |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF -1 MB) | Statistical (PDF -674 KB) | PREA |
| Cinacalcet hydrochloride - Sensipar |
CDTL (PDF - 2.2 MB) Medical (PDF - 4.1 MB) |
Clinical pharmacology (PDF - 5.6 MB) | Statistical (PDF - 957 KB) | BOTH | |
| Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution | Laboratorios SALVAT, S.A. | Medical (PDF - 4MB) | Clinical pharmacology (PDF -632 KB) | Statistical (PDF -2MB) | PREA |
| Ciprofloxacin otic suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 233 KB) | Clinical pharmacology (PDF - 79 KB) | Statistical (PDF - 213 MB | PREA |
| 6% Ciprofloxacin Otic Suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 2.3MB) | Clinical pharmacology (PDF - 97 KB) | Statistical (PDF -896 KB) Addendum (PDF -157 KB |
PREA |
| Ciprofloxacin ophthalmic solution - Ciloxan | Novartis Pharmaceuticals Corporation |
Medical (PDF - 110 KB) Medical (PDF - 173 KB) |
None | None | BPCA |
|
Clascoterone - Winlevi |
Cassiopea SpA | Medical (PDF - 3 MB) | None | None | PREA |
|
Clindamycin phosphate, adapalene, and benzoyl peroxid - Cabtreo |
Bausch Health US, LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Clindamycin phosphate - Xaciato | Daré Bioscience Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Clonidine hydrochloride extended-release oral suspension - Onyda XR NEW | Tris Pharma, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Clonidine - Kapvay | Concordia Pharms Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF -2MB) | PREA |
| Cobicistat - Tybost | Gilead Sciences, Inc. | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Cobimetinib - Cotellic |
Genentech, Inc. | Medical (PDF - 27 KB) | Clinical pharmacology (PDF - 543 KB) | None | BPCA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | CDTL (PDF - 2 MB) Medical (PDF - 12MB) |
Clinical pharmacology (PDF - 7 MB) | None | PREA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF - 308 KB) | PREA |
| Crisaborole Ointment, 2% - Eucrisa | Anacor Pharmaceuticals Inc. | CDTL Review (PDF - 2MB) Medical (PDF - 12MB) |
Clinical pharmacology (PDF - 7MB) | Statistical (PDF - 1MB) | PREA |
| Crisaborole - Eucrisa | Anacor Pharmaceuticals, LLC. | Medical (PDF - 2 MB) | None | None | PREA |
| Crisaborole - Eucrisa | Pfizer | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Cysteamine bitartrate - Procysbi | Raptor Pharmaceuticals, Inc. | Medical (PDF -12MB) | Clinical pharmacology (PDF - 2 MB) Clinical pharmacology addendum (PDF - 420 KB) |
None | BPCA |
| Cysteamine bitartrate - Procysbi | Horizon Pharma USA, Inc. |
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | BPCA |
| Cysteamine hydrochloriden - CYSTADROPS | Recordati Rare Diseases Inc. | Medical (PDF - 294 KB) | None | None | PREA |
| Dabigatran etexilate - Pradaxa |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) Medical (PDF - 700 KB) |
Clinical pharmacology (PDF - 5 MB) | None | BOTH |
| Dabrafenib - Tafinlar | Novartis Pharmaceuticals Corporation | Medical (PDF - 18 MB) | None | None | PREA |
| Dabrafenib - Tafinlar | Novartis Pharmaceuticals Corporation | Medical (PDF - 10 MB) CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF - 579 KB) | None | BPCA |
|
Dalbavancin hydrochloride - Dalvance |
Allergan Sales, LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Dalteparin sodium - Fragmin | Pharmacia & Upjohn, a subsidiary of Pfizer Inc. | Medical (PDF - 3.5 MB) | None | None | PREA |
| Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide - Symtuza | Jannsen | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 1.2MB) | None | PREA |
| Dapsone - Aczone | Allergan, Inc. | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 2.6 MB) | Statistical (PDF -1.3 MB) | PREA |
| Dapsone - Aczone | Almirall, LLC | Medical (PDF - 3.5 MB) | Clinical pharmacology (PDF - 2.6 MB) | None | PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 505 KB) | Clinical pharmacology (PDF - 1.8 MB) |
Statistical (PDF -1.9 KB) |
PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 389 KB) |
Clinical pharmacology (PDF - 991 KB) Clinical pharmacology Addendum (PDF - 80 KB) |
Statistical (PDF - 374 KB) |
PREA |
| Daptomycin - Dapzura RT |
Baxter Healthcare Corporation | Medical (PDF - 2 MB) | None | None | PREA |
| Darbepoetin alfa - Aranesp | Amgen Inc. | Medical (PDF - 2 MB) | None | Statistical (PDF -280KB) | BPCA |
| Darunavir and Cobicistat - Prezcobix | Janssen Products, LP | Medical (PDF - 147 KB) | Clinical pharmacology (PDF - 20 KB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | Medical (PDF -1MB) | Clinical pharmacology (PDF -1MB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | None | Clinical pharmacology (PDF -352KB) | None | PREA |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza | Janssen Products, L.P. | Multi-disciplinary review (PDF - 8 MB) | None | None | PREA |
|
Dasatinib - Sprycel
|
Bristol-Myers Squibb Company |
CDTL Review (PDF - 1 MB) Medical (PDF- 8 MB) |
Clinical pharmacology (PDF - 531 KB) |
Statistical (PDF - 19 KB) | BPCA |
| Dasiglucagon - Zegalogue | Zealand Pharma A/S | Medical (PDF - 5MB) |
Clinical pharmacology (PDF - 33KB) Clinical pharmacology Addendum (PDF - 38KB) |
Statistical (PDF - 2MB) | PREA |
| Daunorubicin and cytarabine (liposome injection) - Vyxeos | Jazz Pharmaceuticals | Multidisciplinary (PDF - 5 MB) | None | None | BPCA |
| Decitabine - Dacogen | Eisai Inc. | Medical (PDF -2 MB) | Clinical pharmacology (PDF -1MB) | None | BPCA |
| Deferasirox - Exjade | Novartis Pharmaceuticals Corporation | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 1.5MB) | Statistical (PDF - 2MB) | BPCA |
| Deferasirox - Exjade | Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 795 KB) Medical (PDF - 843 KB) |
None | None | BPCA |
| Deferasirox - Jadenu | Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 2MB) Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1MB) | None | BPCA |
| Desoximetasone - Topicort | Taro Pharmaceuticals U.S.A., Inc. | Medical (PDF - 221 KB) | Clinical pharmacology (PDF - 302 KB) | None | PREA |
| Desvenlafaxine - Pristiq | Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. |
Medical (PDF - 103 KB) Medical (PDF - 622 KB) |
Clinical pharmacology (PDF - 1.5 MB) | Statistical (PDF - 1.5 MB) | PREA |
|
Deutetrabenazine - Austedo |
Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 622 KB) | None | None | BPCA |
| Dexlansoprazole - Dexilant | Takeda Pharmaceuticals USA Inc. | CDTL Review (PDF-661 KB) Medical (PDF-5 MB) |
Clinical pharmacology (PDF-1MB) | Statistical (PDF-50KB) | PREA |
| Dexmedtomidine hydrochloride - Precedex | Hospira | Medical (PDF -5MB) | Clinical pharmacology (PDF -3.8MB) | Statistical (PDF -1MB) | BPCA |
| Dexmedetomidine - Precedex | Hospira, Inc. | CDTL Review (PDF - 3 MB) | Clinical pharmacology (PDF -3.8MB) | Statistical (PDF - 1MB) | PREA |
| Dextroamphetamine - Xelstrym | Noven Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
|
Diclofenac epolamine topical system 1.3% - Flector |
IBSA Institut Biochimique SA |
Medical (PDF - 1 MB) |
None | None | PREA |
| Diclofenac potassium - Zipsor |
Assertio Therapeutics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 453 KB) | None | PREA |
| Difluprednate ophthalmic emulsion - Durezol | Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd | Medical (PDF -748 KB) | Clinical pharmacology (PDF - 40KB) | Statistical (PDF - 479KB) | BPCA |
| Dolutegravir and lamivudine - Dovato | ViiV Healthcare Company | Medical (PDF - 2 MB) | None | None | PREA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF - 8MB) | Clinical pharmacology (PDF -11 MB) | Statistical (PDF -4MB) | PREA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF - 2 MB) CDTL Review (PDF - 932 KB) |
Clinical pharmacology (PDF -2.2MB) | None | PREA |
| Dolutegravir - Tivicay PD | ViiV Healthcare | Medical (PDF - 241KB) | Clinical pharmacology (PDF -89KB) | None | PREA |
| Doravirine/lamivudine/tenofovir disoproxil fumarate - Delstrigo | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | CDTL Review (PDF - 962 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Doxycycline hyclate delayed-release - Doryx | Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC | Medical (PDF - 241 KB) | Clinical pharmacology (PDF - 89 KB) | Statistical (PDF - 131 KB) | PREA |
| Doxycycline hyclate - LymePak | Chartwell Pharma NDA B2 Holdings, LLC | Medical (PDF - 1 MB) | None | None | PREA |
| Drospirenone and estetrol tablets - Nextstellis |
Mayne Pharma LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Drospirenone - Slynd | Exeltis USA, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| Dulaglutide - Trulicity | Eli Lilly and Company | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 2 MB) | BOTH |
| Duloxetine - Cymbalta | Eli Lilly and Company, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -197KB) | Statistical (PDF - 3 MB) | PREA |
| Duloxetine - Cymbalta | Eli Lily and Company, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Duloxetine delayed-release capsules - Drizalma Sprinkle |
Sun Pharma Global FZE | Medical (PDF - 2 MB) | None | None | PREA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 959 KB) | Statistical (PDF -665 KB) | BPCA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Econazole nitrate - Ecoza | AmDerma Pharmaceuticals, LLC | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 422KB) | PREA |
| Edoxaban - Savaysa | Daiichi Sankyo, Inc. |
CDTL (PDF - 4 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Efavirenz, lamivudine, tenofovir - Symfi Lo | Mylan Pharmaceuticals, Inc. | Medical (PDF - 129 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Efavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi | Mylan Pharmaceuticals, Inc. | Medical (541 - KB) | None | None | PREA |
| Efavirenz, Lamivudine and Tenofovir disoproxil fumarate | Aurobindo Pharma Limited, India | DD Review (PDF - 65 KB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
|
Efavirenz, lamivudine, tenofovir disoproxil fumarate
|
Macleods Pharmaceuticals Limited, India | Medical (PDF - 1.9MB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
| Efavirenz - Sustiva | Bristol-Myers Squibb Company | Medical (PDF -1.9MB) | Clinical pharmacology (PDF -9.3MB) | None | BOTH |
| Efinaconazole - Jublia |
Bausch Health Americas, Inc. |
Medical (PDF - 538 KB) | None | None | PREA |
|
Elbasvir and grazoprevir - Zepatier |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Eltrombopag - Alvaiz | Teva Pharmaceuticals Inc. |
CDTL (PDF - 2 MB) Medical (PDF - 583 MB) |
Clinical pharmacology (PDF - 975 MB) | None | PREA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF -1MB) | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 58 KB) | None | None | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 97 KB) | BPCA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF -13.4MB) | Clinical pharmacology (PDF -24.2MB) | Statistical (PDF -2.2MB) | PREA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF - 242 KB) | None | BOTH |
|
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya |
Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | Clinical pharmacology (PDF - 9 MB) | None | BOTH |
| Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild | Gilead Sciences, Inc. | CTDL Review (PDF -359KB) | Clinical pharmacology (PDF - 462KB) | None | PREA |
| Empagliflozin - Jardiance | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical - CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | BPCA |
| Empagliflozin and Metformin - Synjardy | Boehringer Ingelheim Pharmaceuticals, Inc. | CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 3 MB) | BPCA |
| Empagliflozin and Metformin - Synjardy XR | Boehringer Ingelheim Pharmaceuticals, Inc. | CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 3 MB) | BPCA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey | Gilead Sciences, Inc. | Medical (PDF - 310KB) CTDL Review (PDF - 578KB) |
Clinical pharmacology (PDF - 5MB) Clinical pharmacology addendum (PDF - 297 KB) |
None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 1 MB) Addendum (PDF - 572KB) |
Clinical pharmacology (PDF -8 MB) | Statistical (PDF -2 MB) | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 8 MB) | Statistical (PDF - 2 MB) | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF -145 KB) | None | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | CDTL Review (PDF - 2 MB) | None | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera | Gilead Sciences, Inc. | Medical (PDF - 1MB) | Clinical pharmacology (PDF -145 KB) | None | PREA |
| Emtricitabine and Tenofovir disoproxil fumarate - Truvada | Gilead Sciences, Inc. | Medical (PDF - 501KB) | Clinical pharmacology (PDF -189KB) | None | PREA |
| Entecavir - Baraclude | Bristol-Myers Squibb Company | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 3MB) | Statistical (PDF -660 KB) | BOTH |
| Entrectinib - Rozlytrek | Genentech | Medical (PDF - 23 MB) | None | None | BPCA |
| Entrectinib - Rozlytrek | Genentech, Inc. | Medical (PDF - 14 MB) | None | None | BPCA |
| Erlotinib - Tarceva | OSI Pharmaceuticals, LLC | Medical (PDF - 6 MB) | Clinical pharmacology (PDF -2 MB) | None | BPCA |
| Eribulin mesylate - Halaven | Eisai Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Epinephrine - Auvi-Q | Kaleo, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Epinephrine - Primatene Mist | Armstrong Pharmaceuticals, Inc. |
CDTL Review (PDF - 2 MB) Medical (PDF - 4 MB) |
None | Statistical (PDF - 660 KB) | PREA |
| Escitalopram oxalate - Lexapro | Forest Laboratories, Inc. | Medical (PDF - 218 KB) | None | None | PREA |
| Escitalopram - Lexapro | AbbVie Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Eslicarbazepine acetate - Aptiom | Sunovion Pharmaceutical Inc. | CDTL Review (PDF - 593 KB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 2.9 KB) | None | PREA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 1MB) | Clinical pharmacology (PDF -883KB) | None | BOTH |
| Etafilcon - Theravision with Ketotifen | Johnson & Johnson Vision Care, Inc. |
DD Review (PDF - 2 MB) Medical (PDF - 460 KB) |
None | Statistical (PDF - 3 MB) | PREA |
| Etanercept - Enbrel | Immunex Corporation, a wholly-owned subsidiary of Amgen Inc. |
Medical (PDF - 4.8 MB) DD Review (PDF - 568 KB) CDTL Review PDF - 504 KB) |
Clinical pharmacology (PDF - 702 KB) | Statistical (PDF - 444 KB) | PREA |
| Etanercept - Enbrel | Amgen Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Etanercept-szzs - Erelzi | Sandoz Inc. | Medical (PDF - 1.7 MB) | Clinical pharmacology (PDF - 4.7 MB) | Statistical (PDF - 432 KB) | PREA |
| Etanercept-szzs - Erelzi |
Sandoz Inc. |
CDTL Review PDF - 504 KB) |
None | None | PREA |
| Etanercept-szzs - Erelzi |
Sandoz Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF -1.4MB) | Clinical pharmacology (PDF -1.7MB) | None | BOTH |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 896 KB) | None | BOTH |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical (PDF -10MB) | Clinical pharmacology (PDF -2MB) | None | BPCA |
| Evolocumab - Repatha | Amgen, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Exenatide - Bydureon | AstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LP | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB) | BOTH |
| Exenatide - Byetta | AstraZeneca AB | Medical (PDF - 802 KB) | Clinical pharmacology (PDF - 14 KB) | Statistical (PDF - 122 KB) | BOTH |
| Fenfluramine HCl - Fintepla |
Zogenix, Inc. | Medical (PDF - 588 KB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Ferric oxyhydroxide - Velphoro | Vifor Fresenius Medical Care Renal Pharma France | Medical (PDF - 1 MB) | None | None | BPCA |
| Ferric carboxymaltose -Injectafer | American Regent, Inc. | Medical (PDF - 613 KB) | Clinical pharmacology (PDF - 7 MB) | None | PREA |
| Fesoterodine fumarate - Toviaz | Pfizer, Inc. |
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 300 KB) | PREA |
|
Fidaxomicin - Dificid |
Cubist Pharmaceuticals LLC | Medical (PDF -3.8MB) | None | None | BPCA |
| Filgrastim-sndz - Zarxio | Sandoz, Inc. | Medical (PDF -3.8MB) DD Review (PDF -86KB) TL Review (PDF -422KB) |
Clinical pharmacology (PDF -2.75MB) Addendum (PDF - 1.1MB) |
Statistical (PDF -6742KB) | PREA |
| Filgrastim-aafi - Nivestym | Hospira, Inc. |
CDTL Review (PDF - 746 KB) Medical (PDF - 245 KB) |
Clinical pharmacology (PDF - 661 KB) | Statistical (PDF - 377 KB) | PREA |
| Finafloxacin otic suspension - Xtoro | Alcon Research, Ltd. | Medical (PDF -6.8MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -3.2MB) | BOTH |
| Fingolimod - Gilenya | Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 2 MB) Medical (PDF - 3.8 MB) |
Clinical pharmacology (PDF -2MB) | Statistical (PDF -3.2MB) | BOTH |
| Fingolimod - Tascenso ODT | Handa Neuroscience, LLC |
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Fluticasone furoate inhalation powder - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF -8.6MB) | Clinical pharmacology (PDF -5.7MB) | Statistical (PDF -1.9) | PREA |
| Fluticasone furoate - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF - 956 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 507 KB) | PREA |
| Fluticasone furoate - Arnuity Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | Medical (PDF - 956 KB) | None | None | PREA |
| Fluticasone furoate - Flonase Sensimist Allergy Relief | Haleon US Holdings | Medical (PDF - 489 KB) | None | Statistical (PDF - 133 KB) | PREA |
| Fluticasone Furoate/Umeclidinium/Vilanterol - Trelegy Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | Medical (PDF - 3MB) | None | None | PREA |
| Fluticasone furoate/vilanterol - Breo Ellipta |
GlaxoSmithKline | Medical (PDF - 16 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 4 MB) | PREA |
| Fluticasone furoate and vilanterol - Breo Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England C/o GlaxoSmithKline Research & Development | Medical (PDF - 6 MB) | None | None | BPCA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.4MB) | None | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical (PDF -1 MB) | Clinical pharmacology (PDF -267KB) | Statistical (PDF -52 KB) | PREA |
| Fluticasone propionate - ArmonAir RespiClick | Teva Pharmaceutical Industries Ltd. | Medical (PDF -10 MB) | Clinical pharmacology (PDF - 4.3MB) | Statistical (PDF -1.2 KB) | PREA |
|
Fluticasone propionate - ArmonAir RespiClick |
Teva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc. | Medical (PDF - 6 MB) | None | None | BOTH |
| Fluticasone propionate/salmeterol - AirDuo | Teva Pharmaceutical Industries Ltd. | Medical (PDF -10 MB) | Clinical pharmacology (PDF - 4.3 MB) | Statistical (PDF -1.2 KB) | PREA |
|
Formoterol fumarate and mometasone furoate - Dulera |
Merck Sharp & Dohme Corp. | Medical (PDF - 10 MB) | None | None | BOTH |
| Fosaprepitant - Emend | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 662 KB) | BOTH |
| Fosaprepitant - Focinvez |
Spes Pharmaceuticals Inc. |
Unireview (PDF - 248 MB) Unireview (PDF - 1 MB) |
None | None | PREA |
| Fosphenytoin sodium - Cerebyx | Parke-Davis, a Division of Pfizer, Inc. | CDTL Review (PDF - 390 KB) Medical (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 5 MB) | None | BPCA |
| Gadobutrol - Gadavist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 958KB) | Clinical pharmacology (PDF -2.2MB) | Statistical (PDF -422 KB) | PREA |
| Gadobutrol - Gadavist | Bayer Healthcare Pharmaceuticals, Inc. | Medical (PDF - 7MB) | None | Statistical (PDF -782 KB) | PREA |
|
Gadopiclenol - Elucirem |
Guerbet LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF - 3MB) | Clinical pharmacology (PDF -768KB) | Statistical (PDF -1.2 MB) | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF 1.3 MB) | Clinical pharmacology (PDF - 1.5 MB) | Statistical (PDF - 398 KB) | PREA |
| Gadoteridol - ProHance | Bracco Diagnostics, Inc | Medical (PDF - 3 MB) | None | None | PREA |
| Gadoxetate disodium - Eovist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF -1.2MB) | Clinical pharmacology (PDF -1.5MB) | None | PREA |
| Gatifloxacin ophthalmic solution - Zymar | Allergan, Inc. | Medical (PDF - 78 KB) | None | None | BPCA |
| Gatifloxacin - Zymar | Allergan, Inc. | DDTL (PDF - 428 KB) | None | None | Both |
|
Gepirone - Exxua |
Fabre-Kramer Pharmaceuticals, Inc. | Medical (PDF - 10 MB) | None | None | Both |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. |
CTDL (PDF - 2 MB) CTDL Addendum (PDF - 187 KB) |
Clinical pharmacology (PDF - 409 KB) | Statistical (PDF - 439 KB) | PREA |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. | Medical (PDF - 78 KB) | None | None | PREA |
| Glecaprevir and pibrentasvir - Mavyret | AbbVie, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | None | BOTH |
| Glucagon - Gvoke | Xeris Pharmaceuticals, Inc. | Medical (PDF - 3 MB) CTDL Review (PDF - 3 MB |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glucagon - Baqsimi | Eli Lilly and Company |
Medical (PDF - 3 MB) CTDL Review (PDF - 3 MB |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glycopyrronium - Qbrexza | Dermira, Inc. | Medical (PDF - 6 MB) | None | None |
PREA
|
| Golimumab - Simponi | Janssen Biotech, Inc. |
Medical (PDF - 3.1 MB) |
Clinical pharmacology (PDF - 307 KB) | Statistical (PDF - 1.1 MB) | PREA |
| Golimumab - Simponi Aria | Janssen Biotech, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Guanfacine - Intuniv | Shire | Medical (PDF - 2 MB) CTDL Review (PDF -134 KB) |
Clinical pharmacology (PDF - 330 KB) | Statistical (PDF - 544 KB) | Both |
| Guanfacine - Intuniv | Shire | Medical (PDF -3MB) | Clinical pharmacology (PDF - 667KB) | Statistical (PDF -3MB) | PREA |
| Halobetasol - Propionate Ultravate | Sun Pharmaceutical Industries, Inc. | Medical (PDF - 150 KB) | Clinical pharmacology (PDF - 303 KB) | None | PREA |
|
Halobetasol Propionate - Lexette |
Mayne Pharma LLC |
Medical (PDF - 249 KB) | Clinical pharmacology (PDF - 752 KB) | None | BOTH |
| Ibrexafungerp - Brexafemme | SCYNEXIS, Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Ibrexafungerp - Brexafemme | SCYNEXIS, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Ibrutinib - Imbruvica | Pharmacyclics LLC |
Medical (PDF - 20 MB) | None | None | BPCA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | CTDL Review (PDF -134 KB) | Clinical pharmacology (PDF - 752 KB) | None | PREA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | DD Summary Review (PDF -669KB) Medical (PDF -3MB) |
Clinical pharmacology (PDF -3.7MB) | Statistical (PDF -378KB) | PREA |
| IncobotulinumtoxinA - Xeomin | Merz Pharmaceuticals GmbH | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
| incobotulinumtoxinA - Xeomin | Merz Pharmaceuticals GmbH | Medical (PDF - 1 MB) | None | Statistical (PDF - 872 KB) | PREA |
|
Indocyanine green for Injection - Spy Agent Green
|
Novadaq Technologies ULC | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-axxq - Avsola | Amgen, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-dyyb - Inflectra | Celltrion, Inc. | Medical (PDF -5.3MB) Addendum (PDF - 1MB) |
None | Statistical (PDF -2MB) | PREA |
| Infliximab-abda - Renflexis | Samsung Bioepsis Co., Ltd |
CDTL Review (PDF - 1 MB) Medical (PDF - 3.5 MB) Medical 2(PDF - 267 KB) Medical 3 (PDF - 93 KB) |
Clinical pharmacology (PDF - 7.7 MB) |
Statistical (PDF - 959 KB) Statistical 2 (PDF - 602 KB) |
PREA |
| Insulin aspart injection - Fiasp | Novo Nordisk Inc. |
CDTL Review (PDF - 1 MB) Medical (PDF - 3.5 MB) |
Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 905KB) | PREA |
| Insulin Degludec - Tresiba | Novo Nordisk Inc. | CDTL Review (PDF - 7MB) Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 905KB) | PREA |
| Insulin Degludec / Insulin Aspart) - Ryzodeg | Novo Nordisk Inc. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 905 KB) | PREA |
|
Insulin glargine-yfgn - Semglee |
Mylan Pharmaceuticals Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Insulin glargine-aglr - Rezvoglar | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Insulin lispro-aabc - Lyumjev |
Eli Lilly and Company | Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 10 MB) Clinical pharmacology |
Statistical (PDF - 253 KB) | PREA |
| Iodixanol - Visipaque |
GE HealthCare Inc. |
CDTL Review (PDF - 2 MB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 988 KB) | Statistical (PDF - 1.8 MB) | PREA |
| Iohexol - Oraltag | Interpharma Praha, a.s. | Medical (PDF - 91 KB) | Clinical pharmacology (PDF - 294 KB) | Statistical (PDF - 98 KB) | PREA |
| Ipilimumab - Yervoy | Bristol-Myers Squibb Company | Medical (PDF 6 MB) | Clinical pharmacology (PDF - 1.6 MB) | None | BPCA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 114 KB) | Statistical (PDF - 576 KB) | PREA |
| Isavuconazonium sulfate - Cresemba | Astellas Pharma US Inc. | Medical (PDF - 5 MB) | None | None | BPCA |
| Ivabradine - Corlanor | Amgen Inc. |
CDTL (PDF - 3 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 51 KB) | BPCA |
| Ivacaftor - Kalydeco | Vertex Pharmaceuticals Incorporated | Medical (PDF - 4 MB) | None | None | BPCA |
| Ixekizumab - Taltz | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol - Technegas | Cyclomedica Australia Pty Ltd. | Medical (PDF - 1 MB) | None | None | PREA |
| Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage | Jubilant DraxImage, Inc |
Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
| Lacosamide - Motpoly XR | Aucta Pharmaceuticals, Inc. | Medical (PDF - 276 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Lacosamide - Vimpat | UCB, Inc. |
CDTL Review (PDF - 371 KB) Medical (PDF - 915 KB) |
Clinical pharmacology (PDF - 2 MB) | None |
PREA |
| Lacosamide - Vimpat | UCB, Inc. |
Medical (PDF - 541 KB) Medical (PDF - 631 KB) |
Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 700 KB) | Clinical pharmacology (PDF - 800 KB) | None | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 9 MB) | PREA |
| Lactic acid citric acid and K bitartrate - Phexxi | Evofem, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 KB) | Statistical (PDF - 3 76706 KB) | PREA |
| Lamivudine - Epivir | ViiV Healthcare Company | Medical (PDF -4.2 MB) | Clinical pharmacology (PDF - 3 MB) | PREA | |
| Lamivudine and Raltegravir - Dutrebis | Merck Sharp & Dohme Corp. | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 6.4 MB) | None | PREA |
| Lamivudine and tenofovir - Cimduo | Mylan Pharmaceuticals India | Medical (PDF - 73 KMB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
|
Lamivudine and tenofovir disoproxil fumarate - Temixys
|
Celltrion, Inc. |
Medical (PDF - 20 KB) |
Clinical pharmacology (PDF - 1 MB) |
None | PREA |
| Lamotrigine - Lamictal | GlaxoSmithKline LLC | Medical (PDF -18 MB) | Clinical pharmacology (PDF - 793 KB) | Statistical (PDF - 1.8 MB) | PREA |
| Lanadelumab-flyo - Takhzyro | Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 7 MB) | None | None | BPCA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical and CDTL (PDF - 1.5 MB) | Clinical pharmacology (PDF - 539 KB) | Statistical (PDF - 205 KB) | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical (PDF - 426 KB) | None | None | BOTH |
| Lenvatinib - Lenvima NEW | Eisai Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Leuprolide acetate - Fensolvi | Tolmar, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 4 MB | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol hydrochloride - Xopenex | Oak Pharmaceuticals | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol tartrate - Xopenex HFA | Sunovion Pharmaceuticals Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF 1 MB) | PREA |
| Levamlodipine - Conjupri | CSPC Ouyi Pharmaceutical Co., Ltd. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 569 KB) | None | PREA |
| Levetiracetam - Keppra Extended Release Tablets | UCB, Inc. | DD Summary Review (PDF - 202 KB) CDTL Review (PDF - 371 KB) Medical (PDF - 327 KB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Levomilnacipran - Fetzima | AbbVie Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Levonorgestrel - Liletta | Medicines360 | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 1 MB) Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) | PREA |
| Levonorgestrel/ethinyl estradiol tablets | Exeltis |
CDTL (PDF - 9 MB) Medical (PDF - 9 MB) Medical (PDF - 9 MB) |
Clinical pharmacology (PDF - 1 MB) Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 1.5 MB) | PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 4 MB) Clinical pharmacology addendum (PDF - 89KB) |
Statistical (PDF - 1MB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 8MB) | Clinical pharmacology (PDF - 4MB) | Statistical (PDF - 424 KB) | PREA |
|
Levonorgestrel releasing intrauterine system - Liletta |
Medicines360 |
CDTL Review (PDF - 179KB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 168 KB) | PREA |
|
Levonorgestrel - Mirena |
Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Levothyroxine sodium oral solution - Tirosint-SOL | Cromsource, Inc. |
CDTL Review (PDF - 461 KB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Linaclotide - Linzess | AbbVie Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Linagliptin and Metformin Hydrochloride - Jentadueto XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 246 KB) | BOTH |
| Linagliptin and Metformin hydrochloride - Tradjenta | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 246 KB) | BOTH |
| Linagliptin - Tradjenta | Boehringer Ingelheim Pharmaceuticals, Inc | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | BOTH |
| Lipid injectable emulsion - SMOFlipid | Fresenius Kabi USA, LLC | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
|
Liraglutide - Saxenda |
Novo Nordisk, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 2 MB) | PREA |
| Liraglutide - Victoza | Novo Nordisk Inc. | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 864 KB) | Statistical (PDF - 450 KB) | BOTH |
| Lisdexamfetamine dimesylate - Vyvanse | Shire Development, LLC | Medical (PDF - 218 KB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Lisdexamfetamine mesylate - Vyvanse | Shire | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
|
Lisdexamfetamine dimesylate - Vyvanse
|
Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 804 KB) | None | None | BOTH |
| Lisenatide - Adlyxin |
Sanofi-aventis U.S. LLC | Medical (PDF - 182 KB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Lumacaftor and ivacaftor - Orkambi |
Vertex Pharmaceuticals Incorporated | Medical (PDF - 6 MB) | None | None | BPCA |
| Loteprednol - Lotemax | Bausch & Lonb Inc. |
Medical (PDF - 318 KB) Medical (PDF - 218 KB) |
None | Statistical (PDF - 3 MB) | PREA |
| Luliconazole - LuzuTM | Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC |
CDTL (PDF - 358 KB) CDTL (PDF - 372 KB) Medical (PDF - 306 KB) Medical (PDF - 616 KB) |
Clinical pharmacology (PDF -1 MB) Clinical pharmacology (PDF - 423 KB) |
Statistical (PDF - 207 KB) | PREA |
| Lopinavir / Ritonavir - Kaletra | AbbVie Inc. | Medical (PDF - 5.8 MB) | Clinical pharmacology (PDF -2.3 MB) | Statistical (PDF - 2 MB) | PREA |
| Lubiprostone - Amitizia | Sucampo Pharmaceuticals Inc. | Medical (PDF - 11 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Lutetium Lu177 dotatate - Lutathera | Advanced Accelerator Applications USA, Inc. | Medical (PDF - 3 MB) | None | None | BPCA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. |
Medical (PDF - 6 MB) Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 369 KB) Statistical (PDF - 255 KB) |
BOTH |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. |
CDTL (PDF - 6 MB) Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 368 KB) | PREA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | BPCA |
| Memantine hydrochloride - Namenda XR | Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 956 KB) | Statistical (PDF - 1 MB) | BPCA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 6 MB) Clinical pharmacology addendum (PDF - 425 KB) |
Statistical (PDF - 1 MB) | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical(PDF - 8 MB) | None | None | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Mirabegron - Myrbetriq | Astellas Pharma Global Development, Inc. | Medical (PDF - 13 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 168KB) | BOTH |
| Mesalamine - Asacol HD | Warner Chilcott | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 3 MB) Clinical pharmacology (PDF - 518 KB) |
Statistical (PDF -499 KB) | PREA |
| Mesalamine - Canasa | Forest Laboratories | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 251 KB) | Statistical (PDF - 344 KB) | PREA |
| Mesalamine - Delzicol | Warner Chilcott LLC | Medical (PDF - 707 KB) Medical Addendum(PDF - 495 KB) |
Clinical pharmacology (PDF - 116 KB) | None | PREA |
| Mesalamine - Delzicol | Warner Chilcott (US), LLC | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 729 KB) | Statistical (PDF - 1 KB) | PREA |
| Mesalamine - Lialda | Shire Development, LLC | Medical (PDF - 6 MB) | None | None | PREA |
|
Metformin hydrochloride for extended-release oral suspension - Riomet ER |
Pharmaceutical Industries Limited | CTDL Review (PDF - 917 KB) | Clinical pharmacology (PDF - 818 KB) | None | PREA |
| 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief | Hisamitsu Pharmaceutical Co., Inc. | Medical (PDF - 998 KB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
|
Methylphenidate hydrochloride extended-release - Aptensio XR |
Rhodes Pharmaceuticals L.P. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 MB) Statistical (PDF - 629 KB) |
PREA |
| Methylphenidate hydrochloride - Aptensio XR | Rhodes Pharmaceuticals L.P. | CTDL Review (PDF - 592 KB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB) Statistical (PDF - 139 KB) |
BOTH |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical (PDF - 26 KB) | Clinical pharmacology (PDF - 588 KB) | Statistical (PDF - 380 KB) | PREA |
| Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER | Pfizer Inc. | CTDL Review (PDF -1 MB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF -2.9MB) | Statistical (PDF -498KB) | PREA |
|
Methylphenidate HCL extended-release capsules - Adhansia XR |
Purdue Pharma |
Medical (PDF - 2 MB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB) Statistical (PDF - 2 MB) |
PREA |
|
Methylphenidate hydrochloride - Jornay PM
|
Ironshore Pharmaceuticals & Development, Inc. | Medical (PDF - 4.8 MB) | Clinical pharmacology (PDF - 2.1 MB) | Statistical (PDF - 921 KB) | PREA |
| Methylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT | Neos Therapeutics, Inc. |
Medical (PDF - 5.7 MB) Medical (PDF - 1.2 MB) |
Clinical pharmacology (PDF - 2.1 MB) Clinical pharmacology (PDF - 2.1 MB) |
Statistical (PDF - 921 KB) Statistical (PDF - 96 KB) |
PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera | Vifor International AG |
Medical (PDF - 2.3 MB) |
None |
Statistical (PDF - 239 KB) |
PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera | Vifor (International) AG c/o ProPharma Group | Medical (PDF - 7 MB) | Clinical Pharmacology (PDF - 5MB) | Statistical (PDF - 7 MB) | PREA |
| Metoprolol Succinate - KAPSPARGO SPRINKLE | Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 978 KB) | None | PREA |
| Metronidazole - Likmez | Saptalis Pharmaceuticals, LLC | Medical (PDF - 6 MB) | None | None | PREA |
| Metronidazole vaginal gel 1.3% - Nuvessa | Chemo Research SL | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 70 KB) | Statistical (PDF - 127 KB) | PREA |
| Micafungin for injection - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 1 MB) | None | None | BOTH |
|
Micafungin in Sodium Chloride Injection - Micafungi |
Baxter HealthCare Corporation | Medical (PDF - 1 MB) | None | None | PREA |
| Micafungin sodium - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 4.4MB) |
Statistical (PDF -987KB) | BPCA |
| Minocycline - Amzeeq |
Foamix Pharmaceuticals Inc. | Medical (PDF - 2.2 MB) | None | None | PREA |
| Mirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq Granules | Astellas Pharma Global Development, Inc. | Medical (PDF - 13 MB) | None | None | BOTH |
| Mixed salts of a single-entity amphetamine product - Mydayis | Shire Development, LLC. |
Medical (PDF - 7 MB) |
Clinical pharmacology (PDF -1.8KB) | Statistical (PDF -987KB) | PREA |
| Mixed salts of a single entity amphetamine product - Mydayis | Shire Development, LLC. | Medical (PDF - 7 MB) | None | None | BPCA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohme Corp. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF -2 MB) | Statistical (PDF -603KB) | PREA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohm Corp | Medical (PDF- 1 MB) | None | None | PREA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohm Corp | Medical (PDF - 1 MB) | None | None | PREA |
| Mometasone furoate and formoterol fumarate - Dulera | Schering-Plough | Medical (PDF- 1 MB) | None | None | PREA |
| Morphine sulfate - Morphine sulfate | Hospira, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Morphine sulfate - Morphine sulfate | Hikma Pharmaceuticals USA Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
|
Moxifloxacin - Avelox |
Bayer Pharmaceuticals | Medical (PDF- 905 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 760 KB) | PREA |
| Moxifloxacin ophthalmic solution - Vigamox | Alcon Pharmaceuticals, Ltd. | Medical (PDF - 434 KB) DD Summary Review (PDF- 118 KB) |
None | None | BPCA |
| Mycophenolate mofetil - CellCept |
Roche Palo Alto LLC | Medical (PDF - 6 MB) | None | None | PREA |
| Naftifine hydrochloride - Naftin | Merz Pharmaceuticals, LLC | Medical (PDF - 488 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 188 KB) | PREA |
| Naftifine hydrochloride - Naftin Cream, 2% | Merz Pharmaceuticals, LLC | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 822 KB) | PREA |
| Nalmefene - Opvee | Opiant Pharmaceuticals, Inc. |
CTDL Review (PDF - 4 MB) |
Clinical pharmacology (PDF - 9 MB) Clinical pharmacology addendum (PDF - 9 KB) |
Statistical (PDF - 2 MB) | PREA |
| Naloxone hydrochloride - Kloxxado
|
Hikma Pharmaceuticals USA, Inc. |
CTDL Review (PDF - 613 KB) CTDL and DD Review (PDF - 1 MB) Medical (PDF - 4 MB) |
None | None | PREA |
| Naloxone hydrochloride - Narcan Nasal Spray | Adapt Pharma Operations Limited | DD Summary Review(PDF -1 MB) CTDL Review (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Naloxone Hydrochloride Injection - Naloxone Hydrochloride Injection | Kaleo, Inc. | CDTL Review (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Naloxone Hydrochloride - Rextovy | Amphastar Pharmaceuticals, Inc |
Medical (PDF - 3 MB) CDDD Review (PDF - 637 KB) |
Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Naloxone Hydrochloride - Rezenopy | Summit Biosciences |
Medical (PDF - 2MB) CDTL Review (PDF - 3MB) |
Clinical pharmacology (PDF - 1MB) | None | PREA |
| Naloxone hydrochloride - RiVive | Harm Reduction Therapeutics, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
|
Naloxone hydrochloride - Zimhi |
Adamis Pharmaceuticals Corporation | CDTL Review (PDF - 2 MB) | Clinical pharmacology (PDF - 368 KB) | None | PREA |
| Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM | Bayer HealthCare, LLC – Consumer Care | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF -1 MB) | PREA |
| Naproxen and esomeprazole magnesium - Vimovo | Horizon Pharma Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Neostigmine methylsulfate - Bloxiverz | Eclat Pharmaceuticals, LLC | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Neostigmine methylsulfate and glycopyrrolate - Prevduo | Slayback Pharma LLC | CDTL Review (PDF - 794 KB) | Clinical pharmacology (PDF - 284 KB) | None | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -2MB) | Clinical pharmacology (PDF - 446 KB) | Statistical (PDF - 723KB) | PREA |
| Nilotinib - Tasigna | Sponsor: Novartis Pharmaceuticals Corporation | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1.6 MB) | Statistical (PDF - 124 KB) | BPCA |
| Nintedanib - Ofev | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 10 MB) | None | None | BPCA |
| Nirmatrelvir - Ritonavir - Paxlovid | Pfizer, Inc | Medical (PDF - 27 MB) | None | None | PREA |
| Nirsevimab-alip - Beyfortus | AstraZeneca AB | Medical (PDF - 20 MB) | None | None | PREA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | None | None | PREA |
| Nivolumab - Opdivo |
Bristol-Myers Squibb Company |
DD (PDF - 188 KB) Medical (PDF - 222 KB) |
Clinical pharmacology (PDF - 202 KB) Clinical pharmacology (PDF - 250 KB) |
Noen | PREA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | Medical (PDF - 8 MB) | None | None | BPCA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | Medical (PDF - 11 MB) | None | None | BPCA |
|
Nivolumab and relatlimab-rmbw - Opdualag |
Bristol-Myers Squibb Company | Medical (PDF - 29 MB) | None | None | PREA |
| Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla | Warner Chilcott Company, LLC | Medical (PDF -1MB) | Clinical pharmacology (PDF -3.2MB) | Statistical (PDF - 469 KB) | PREA |
| Obiltoxaximab - Anthim | Elusys Theraputics, Inc. | Medical (PDF -18 MB) Addendum (PDF - 249 KB) |
Clinical pharmacology (PDF -12MB) Addendum (PDF -126 KB) |
Statistical (PDF - 9 MB) | PREA |
| Ocriplasmin- Jetrea | ThromboGenics, Inc. | Medical (PDF - 817 KB) | Clinical pharmacology (PDF - 117KB) | Statistical (PDF - 760 KB) | PREA |
| Olanzapine and fluoxetine hydrochloride - Symbyax | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF -1.2MB)
Addendum (PDF - 132KB) |
Statistical (PDF - 953 KB) | PREA |
| Olopatadine - Pazeo | Alcon Research LTD | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -340KB) | Statistical (PDF - 4 KB) | BOTH |
| Olopatadine hydrochloride and mometasone furoate - Ryaltris | Glenmark Specialty SA |
Medical (PDF - 6 MB) CDTL (PDF - 6 MB) |
None | None | PREA |
| Omalizumab - Xolair | Genentech | Medical (PDF - 6 MB) | Clinical pharmacology (PDF -1.3MB) | Statistical (PDF - 2MB) | PREA |
| Omalizumab - Xolair | Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF- 4 MB) | Clinical pharmacology (PDF -1MB) | Statistical (PDF - 1 MB) | PREA |
|
Omalizumab - Xolair
|
Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF - 5 MB) | None | None | PREA |
| Omalizumab - Xolair | Genentech, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Omeprazole magnesium - Prilosec | AstraZeneca Pharmaceuticals LP | Medical (PDF - 908 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
|
OnabotulinumtoxinA - Botox |
Allergan, Inc. |
CDTL (PDF - 403 KB) Medical (PDF - 1 MB) |
None |
Statistical (PDF - 173 KB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc |
Medical (PDF - 3 MB) Medical (PDF - 1 MB) |
None | Statistical (PDF - 1 MB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| OnabotulinumtoxinA - Botox |
Allergan, Inc. | Medical (PDF - 1 MB) | None | Statistical (PDF - 2 MB) | PREA |
| OnabotulinumtoxinA - Botox |
Allergan, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Oxaprozin - Coxanto | Solubiomix, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 482 KB) | PREA |
| Oxycodone hydrochloride - Oxycodone hydrochloride | Genus Lifesciences, Inc. |
Medical (PDF - 2 MB) DD Memo (PDF - 1 MB) |
Clinical pharmacology (PDF - 688 KB) | None | PREA |
| Oxycodone hydrochloride - Oxycontin | Purdue Pharma L.P. | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 678 KB) | BPCA |
| Oxymorphone - Opana | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA | |
| Ozenoxacin - Xepi | Ferrer Internacional S.A. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 524 KB) | PREA |
| Paclitaxel - Abraxane | Abraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene Corporation | Medical (PDF - 235 KB) | None | None | BPCA |
| Palifermin - Kepivance | Quintiles, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 726 KB) | None | PREA |
| Palonosetron hydrochloride - Aloxi | Helsinn Healthcare SA | Medical (PDF - 15 MB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -2 MB) | Statistical (PDF - 771 KB) | BOTH |
| Pancrelipase - Creon | AbbVie Inc. | Medical (PDF - 566 KB) | None | None | PREA |
| Pancrelipase - Pancreaze | Janssen Pharmaceuticals, Inc. | Medical (PDF - 142 KB) | None | None | PREA |
| Pancrelipase - Pertzye | Digestive Care, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical (PDF - 587 KB) | None | None | PREA |
| Paricalcitol - Zemplar | AbbVie Inc. | Medical (PDF - 3 MB) CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 427 KB) | PREA |
| Patiromer - Veltassa | Vifor Pharma, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
|
Pegfilgrastim-cbqv - UDENYCA |
Coherus BioSciences, Inc |
Medical (PDF - 228 KB) CDTL (PDF - 584 KB) |
Clinical pharmacology (PDF - 968 KB) | Statistical (PDF - 199 KB) | PREA |
| Pegfilgrastim-fpgk - Stimufend | Fresenius Kabi USA, LLC | CDTL (PDF - 198 KB) | None | None | PREA |
| Pegfilgrastim-bmez - Ziextenzo | Sandoz Inc. | CDTL (PDF - 348 KB) | None | None | PREA |
| Peginterferon alfa-2a - Pegays | Hoffmann-La Roche, Incorporated | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 667 KB) | Statistical (PDF - 667 KB) | PREA |
| Peramivir - Rapivab | BioCryst Pharmaceuticals, Inc. | Medical (PDF - 767 KB | Clinical pharmacology (PDF -468 KB) | Statistical (PDF - 767KB) | PREA |
| Peramivir - Rapivab |
BioCryst Pharmaceuticals, Inc. | Medical (PDF - 1 MB | Clinical pharmacology (PDF - 81 KB) | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF -6MB) | Statistical (PDF -1.2MB) | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF - 3 MB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -4MB) | Statistical (PDF -1.3MB) | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF - 3 MB) Medical MTL (PDF - 678 KB) |
Clinical pharmacology (PDF -1.2MB) | None | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF - 79 KB) | Clinical pharmacology (PDF - 86 KB) | None | PREA |
|
Perampanel - Fycompa |
Eisai Inc. |
CDTL (PDF - 452 KB) Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 2.5 MB) | None | PREA |
| Perflutren lipid microsphere - DEFINITY and DEFINITY RT |
Lantheus Medical Imaging, Inc. | Medical (PDF - 719 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 858 KB) | PREA |
|
Pentermine and topiramate - Qsymia |
VIVUS LLC | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 587 KB) | Statistical (PDF - 858 KB) | PREA |
| Phentolamine mesylate - OraVerse | Septodont Holding Sas | Medical (PDF - 3 MB) | None | Statistical (PDF - 1 MB) | PREA |
| Phenylephrine hydrochloride ophthalmic solution | Paragon BioTeck, Inc. | Medical (PDF - 1MB) | Clinical pharmacology (PDF - 95 KB) | Statistical (PDF -1 MB) | PREA |
|
Phentolamine ophthalmic solution - Ryzumvi |
Ocuphire Pharma, Inc. |
CDTL (PDF - 1 MB) Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Phenylephrine and ketorolac - Omidria | Omeros Corporation | CDTL (PDF - 1 MB) Medical (PDF - 4 MB) |
None | Statistical (PDF - 816 KB) | BPCA |
| Piperacillin and tazobactam - Zosyn | Wyeth Pharmaceuticals LLC | Medical (PDF - 2 MB) | None | None | PREA |
|
Pitavastatin - Livalo |
Kowa Pharmaceuticals America, Inc. | CDTL Review (PDF - 526 KB) Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 240 KB) | BPCA |
| Pomalidomide - POMALYST | Celgene Corporation | Medical (PDF - 15 KB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 252KB) | PREA |
| Posaconazole - Noxafil | Merck | Medical (PDF - 602 KB) | Clinical pharmacology (PDF - 645 KB) | None | PREA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Potassium phosphate | Fresenius Kabi USA, LLC | Medical (PDF - 602 KB) | None | None | PREA |
| Potassium Phosphates - Potassium Phosphates NEW | CMP Development LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Prasugrel - Effient | Eli Lilly and Company | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 911 KB) | Statistical (PDF -290 KB) | BPCA |
| Pregabalin - Lyrica | Pfizer | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 KB) | Statistical (PDF - 825 KB) | PREA |
| Pregabalin - Lyrica | PF PRISM CV | Medical and Statistical (PDF - 1 MB) | Clinical pharmacology (PDF - 1.3 MB) | Medical and Statistical (PDF - 1 MB) | PREA |
| Pregabalin - Lyrica | Pfizer |
CTDL Review (PDF - 1 MB) Medical (PDF - 1 MB) |
Clinical pharmacology(PDF -1 MB) | Statistical (PDF - 2 MB) | BOTH |
| Quetiapine fumarate - Seroquel and Seroquel XR | AstraZeneca Pharmaceuticals LP |
CTDL Review (PDF - 1 MB) Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 739 KB) |
Statistical (PDF - 785 KB) | PREA |
| Rabeprazole sodium - AcipHex Sprinkle | Eisa Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF 185 KB) | BOTH |
|
Ramucirumab - Cyramza |
Eli Lilly and Company | Medical (PDF - 198 KB) | Clinical pharmacology (PDF - 168 KB) | None | BPCA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF - 1MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | CDTL Review (PDF - 5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF 874 KB) | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
|
Ravulizumab-cwvz - Ultomiris |
Alexion Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. |
Medical (PDF - 1 MB) Medical (PDF - 776 KB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 225 KB) Statistical (PDF - 782 KB) |
PREA |
| Remdesivir - Veklury |
Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | None | None | PREA |
| Remdesivir - Veklury |
Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. | CDTL (PDF - 4 MB) | None | None | BOTH |
| Reslizumab - Cinqair | Teva Respiratory, LLC | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 9 MB) | Statistical (PDF - 2 MB) | PREA |
| Rifapentin - Priftin | Sanofi US Services Inc. | Medical (PDF - MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 3 MB) | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -138 KB) | None | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF - 41 MB) |
Clinical pharmacology (PDF - 2 MB) Clinical pharmacology (PDF - 235 KB) |
PREA | |
| Rilpivirine - Edurant | Janssen Products, LP | Medical (PDF - 9 MB) | None | None | BPCA |
| Rivaroxaban - Xarelto | Janssen Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 10 MB) | Statistical (PDF - 797 KB) | BOTH |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review (PDF - 20 KB) CTDL Review (PDF - 1MB) Medical (PDF - 670KB) Medical (PDF - 667 KB) |
None | Statistical (PDF - 237KB) | PREA |
| Ritlecitinib - Litfulo | Pfizer, Inc. | Medical (PDF - 15 MB) | None | None | PREA |
|
Rituximab-arrx - Riabni |
Amgen, Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Rizatriptan - RizaFilm | IntelGenx Corp. |
Medical (PDF - 352 KB) Memo (PDF - 851 KB) |
Clinical pharmacology (PDF - 220 KB) | None | PREA |
| Roflumilast - Zoryeve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
|
Roflumilast - Zoryeve |
Arcutis Biotherapeutics, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Roflumilast - Zoryeve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Rosuvastatin - Ezallor Sprinkle | Sun Pharmaceutical Industries Limited | Medical (PDF - 27 KB) | None | None | PREA |
| Rufinamide - Banzel | Eisai Inc. | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 3MB) | None | BPCA |
| Ruxolitinib - Jakafi | Incyte Corporation |
Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | None | BPCA |
| Ruxolitinib - Jakafi | Incyte Corporation | Medical (PDF - 685 KB) | None | None | BPCA |
|
Ruxolitinib - Opzelura |
Incyte Corporation | Medical (PDF - 9 MB) | None | None | PREA |
| Ruxolitinib - Opzelura | Incyte Corporation | Medical (PDF - 7 MB) | None | None | PREA |
| Sacubitril-valsartan - Entresto | Novartis Pharmaceuticals Corp. | Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | Statistical (PDF -1MB) | BPCA |
| Sacubitril-valsartan - Entresto | Novartis Pharmaceuticals Corp. |
CDTL (PDF - 727 KB) Medical (PDF - 9 MB) |
Clinical pharmacology (PDF - 6 MB) | None | PREA |
| Sapropterin dihydrochloride - Kuvan | BioMarin Pharmaceutical Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF -3 MB) | None | BPCA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -1MB) | BOTH |
|
Sarecycline - Seysara |
Allergan, Inc. | Medical (PDF -1 MB) | None | None | PREA |
| Secnidazole - Solosec | Lupin Pharmaceuticals, Inc. | Medical (PDF 4 MB) | None | None | PREA |
| Secnidazole - Solosec | Lupin Pharmaceuticals, Inc. (A subsidiary of Lupin Inc.) | Medical (PDF 2 MB) | None | None | PREA |
|
Secukinuma - Cosentyx |
Novartis Pharmaceuticals Corporation | Medical (PDF - 6 MB) | None | None | PREA |
| Selegiline - Emsam | Somerset Pharmaceuticals | Medical (PDF -1 MB) Medical 2 (PDF -1 MB) Medical Secondary 1 (PDF - 349 KB) Medical Secondary 2 (PDF -188 KB) |
None | None | PREA |
| Selenious Acid - Selenious Acid | American Regent, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Selenious Acid - Selenious Acid | American Regent, Inc. | Medical (PDF - 8 MB) |
None |
None | PREA |
| Segesterone acetate and ethinyl estradiol vaginal systems - Annovera | The Population Council, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Semaglutide - Wegovy | Novo Nordisk Inc. |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 16 MB) | Statistical (PDF - 869 KB) | PREA |
| Serdexmethylphenidate and dexmethylphenidate - Azstarys | Commave Therapeutics | Multidisciplinary (PDF - 7 MB) | None | None | PREA |
| Sevelamer Carbonate - Renvela | Genzyme/Sanofi | Medical (PDF - 745 KB) | Clinical pharmacology (PDF - 542 KB) | Statistical (PDF - 541KB) | PREA |
|
Sitagliptin - Januvia, Janumet & Janumet XR
|
Merck Sharp & Dohme Corp.: |
CDTL (PDF - 1 MB) Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 339 KB) | Statistical (PDF - 623 KB) | BOTH |
| Sildenafil - Revatio | Pfizer, Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF - 508 KB) | BOTH |
| Sodium oxybate - Xyrem | Jazz Pharmaceuticals |
Medical (PDF - 193 KB) | Clinical pharmacology (PDF - 2MB) | Statistical (PDF - 508 KB) | BPCA |
| Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik | Ferring Pharmaceuticals Inc. | Medical (PDF - 193 KB) | None | None | PREA |
| Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit | Sponsor: Braintree Laboratories, Inc. |
Medical (PDF - 193 KB) |
None | None | PREA |
|
Sodium picosulfate, magnesium oxide and anhydrous citric acid - Clenpiq |
Ferring Pharmaceuticals Inc. |
CDTL (PDF - 1 MB) | None | None | PREA |
| Sofpironium - Sofdra | Botanix SB Inc. |
Uniview (PDF - 4 MB) Medical (PDF - 133 KB) |
None | None | PREA |
| Spinosad - Natroba | ParaPRO, LLC | Medical (PDF - 854 KB) | Clinical pharmacology (PDF -171KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical and CDTL (PDF - 345 KB) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical (PDF - 218 KB) | None | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 218 KB) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 287 KB) | Clinical pharmacology (PDF - 4 MB) | None | BOTH |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 933KB) | Statistical PDF - 960 KB) | BOTH |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 3 MB) CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF -2MB) | Statistical (PDF - 960 KB) | BOTH |
| Spinosad - Natroba | ParaPRO LLC | Medical (PDF - 458 KB) | None | None | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - Lumason | Bracco Diagnostics Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF -2MB) | Statistical (PDF -792KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF - 3MB) CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF - 1MB) | Statistical (PDF - 859 KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -843 KB) | PREA |
| Sugammadex - Bridion |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 3 MB | Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) | PREA |
| Sumatriptan/Naproxen - Treximet | Pernix Therapeutics | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -843 KB) Statistical Addendum (PDF -702 KB) |
BOTH |
| Sunitinib malate - Sutent | C.P. Pharmaceuticals International C.V. | CDTL (PDF - 680 KB) | None | None | BPCA |
| Tacrolimus - Astagraf XL |
Astellas Pharma US, Inc.
|
Medical (PDF - 749 KB) | None | None | PREA |
| Tadalafil - Cialis | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Tapentadol - Nucynta | Collegium Pharmaceutical, Inc. | CDTL - DD (PDF - 9 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -700 KB) | PREA |
| Tapentadol - Nucynta NEW | Collegium Pharmaceutical, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Tavaborole - Kerydin | Anacor Pharmaceuticals, Inc. | Multi-disciplinary review (PDF - 2.5 MB) | None | None | BOTH |
| Tazarotene - Arazlo | Bausch Health US, LLC | Clinical (PDF - 1 MB) | None | None | PREA |
| Tbo-filgrastim - Granix | Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D |
CDTL (PDF - 176 KB) Clinical (PDF - 196 KB) |
Clinical pharmacology (PDF - 434 KB) | None | BOTH |
| Technetium 99m Tilmanocept - Lymphoseek | Cardinal Health 414, LLC | Multidisciplinary (PDF - 2 MB) | None | None | PREA |
| Kit for the Preparation of Technetium Tc 99m Succimer Injection -NephroScan | Theragnostics Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Tedizolid phosphate - Sivextro | Cubist Pharmaceuticals, LLC | Medical (PDF - 9 MB) | None | None | PREA |
| Teduglutide - GattexShire | Shire-NPS Pharmaceuticals, Inc. | Medical (PDF - 9 MB) | None | None | PREA |
| Tenofovir alafenamide - Vemlidy | Gilead Sciences, Inc | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 624 KB) | PREA |
| Tenofovir alafenamide - Vemlidy | Gilead Sciences, Inc | Medical (PDF - 3 MB) | None | None | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | CDTL (PDF - 873 KB) | Clinical pharmacology (PDF - 180 KB) | Statistical (PDF - 149 KB) | BOTH |
| Teplizumab-mzwv -Tzield | Provention Bio, Inc. |
CDTL (PDF - 5 MB) Medical (PDF - 284 KB) |
Clinical pharmacology (PDF - 6 MB) | None | PREA |
| Teriflunomide - Aubagio | Sanofi |
CTDL (PDF - 3 MB) Clinical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 410KB) | BOTH |
| Tetracaine hydrochloride - Steri-Unit | Alcon Research, Ltd. | DD Medical Summary (PDF - 2 MB) Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 158 KB) | Statistical (PDF - 2 MB) | PREA |
| Tetracaine HCl and Oxymetazoline HCl - Kovanaze | St. Renatus, LLC | Medical (PDF - 12 MB) | Clinical pharmacology (PDF - 11 MB) | Statistical (PDF - 2 MB) | PREA |
|
Tezepelumab -Tezspir |
AstraZeneca | Medical (PDF - 10 MB) | None | None | PREA |
| Ticagrelor - Brilinta |
AstraZeneca Pharmaceuticals LP | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 325 KB) | BPCA |
| Tilmanocept - Lymphoseek |
Cardinal Health 414, LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF -11.9MB) Medical Addendum (PDF - 418 KB |
Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 1 MB) Statistical Addendum (PDF - 327 KB) |
PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 2MB) | Statistical (PDF - 432K B) | BOTH |
| Tobramycin 300 mg/4mL inhalation solution - Bethkis | Cornerstone Therapeutics | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 78 KB) | Statistical (PDF - 687 KB) | PREA |
|
Tocilizumab - Actemra |
Genentech, Inc. |
Medical (PDF - 72 KB) Medical (PDF - 109 KB) |
Clinical pharmacology (PDF - 195 KB) | None | PREA |
|
Tocilizumab - Actemra
|
Genentech, Inc. | Medical (PDF - 8 MB) | None | None | BOTH |
| Tocilizumab-bavi - Tofidence | Biogen MA Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Tocilizumab-aazg -Tyenne | Fresenius Kabi USA, LLC |
CDTL (PDF - 42K B) Medical (PDF - 8 MB) |
None | None |
PREA |
| Tofacitinib - Xeljanz | Pfizer, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Topiramate - Topamax | Janssen Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | Statistical (PDF - 881 KB) | PREA |
|
Topiramate - Eprontia |
Azurity Pharmaceuticals, Inc. | Medical (PDF - 669 KB) | Clinical pharmacology (PDF - 565 KB) | None | PREA |
| Trabectedin - Yondelis | Janssen Products, LP | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 683 KB) | None | BPCA |
| Trace elements injection 4 - Tralement | American Regent, Inc. | Medical (PDF - 2.5 MB) | None | None | PREA |
| Trace elements injection 4 - Tralement | American Regent, Inc. | Medical (PDF - 321 KB) | None | None | PREA |
| Tralokinumab-ldrm - Adbry | LEO Pharma A/S c/o LEO Pharma Inc |
Unireview (PDF - 4MB) Medical (PDF - 32 KB) |
None | None | PREA |
| Trametinib - Mekinist | Novartis Pharmaceuticals Corporation |
Medical (PDF - 18 MB) | None | None | PREA |
| Trametinib - Mekinist | Novartis Pharmaceuticals Corporation | Medical (PDF - 800 KB) | Clinical pharmacology (PDF - 616 KB) | None | BPCA |
| Tranexamic acid - Lysteda | Ferring Pharmaceuticals, Inc. | None | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Tretinoin lotion - Altreno | Dow Pharmaceutical Sciences, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Tretinoin and benzoyl peroxide - Twyneo | Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Trifarotene - Aklief | Galderma Research and Development | Medical (PDF - 3 MB) | None | None | PREA |
| Trofinetide - Daybue | Acadia Pharmaceuticals Inc |
Medical (PDF - 212 KB) Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 6 MB) |
Statistical (PDF - 2 MB) Statistical Errata (PDF - 28 KB) |
BPCA |
| Tropicamide and phenylephrine - MYDCOMBI | Eyenovia, Inc. | CDTL - DD (PDF - 6 MB) | None | Statistical (PDF - 2 MB) | PREA |
| Upadacitinib - Rinvoq | AbbVie Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Upadacitinib - Rinvoq and Rinvoq LQ | AbbVie Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech, Inc. | Medical (PDF - 352 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Ustekinumab-aekn - Selarsdi | Alvotech USA Inc. PharmaLex US Corporation |
CDTL (PDF - 123 KB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 9 KB) | None | PREA |
| Valganciclovir hydrochloride - Valcyte | Roche Palo Alto LLC c/o Genentech, Inc.orporated | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 6 MB) | None | PREA |
|
Valsartan - Diovan |
Novartis Pharmaceuticals Corporation | Medical (PDF - 2 MB) | None | None | PREA |
|
Varenicline - Chantix
|
PF Prism C V | None | Clinical pharmacology (PDF - 3 MB) | None | BOTH |
| Vilazodone hydrochloride - Viibryd | Allergan Sales, LLC | Medical (PDF - 3 MB) | None | None | BOTH |
|
Vortioxetine - Trintellix |
Takeda Pharmaceuticals, USA, Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Vortioxetine - Trintellix | Takeda Pharmaceuticals, USA, Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Ustekinumab - Stelara | Janssen Biotech Inc. |
CDTL (PDF - 593 KB) Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 275 KB) | PREA |
| Vigabatrin - Sabril | Lundbeck LLC. | Medical (PDF - 4MB) | Clinical pharmacology (PDF - 2.3MB) | Statistical (PDF - 698KB) | BOTH |
| Viloxazine extended release capsules - Qelbree |
Supernus Pharmaceuticals, Inc. |
Medical (PDF - 13 KB) Medical (PDF - 13 MB) |
None | None | PREA |
| Viloxazine extended-release capsules - Qelbree | Supernus Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Voriconazole - Vend | PF PRISM C.V. |
Medical (PDF - 2 MB) Medical PDF - 200 KB) |
Clinical Pharmacology (PDF - 1 MB) | Statistical (PDF - 200 KB) | PREA |
| Xenon Xe 129 hyperpolarized - XENOVIEW | Polarean Inc. | Medical PDF - 200 KB) | None | None | PREA |
| Zinc sulfate - None | American Regent, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ziprasidone - Geodon |
Viatris Specialty LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Zolmitriptan - Zomig | AstraZeneca Pharmaceuticals LP | Medical (PDF - 5 MB) | None | Statistical (PDF - 3 MB) | PREA |