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  1. Development Resources

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

As required by the Pediatric Research Equity Act of 2012 (PREA), as amended by FDASIA (Public Law 112-144), 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 = 68
Total Number of Products Studied under PREA = 444
Total Number of Products Studied under Both = 73

Drug  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) BOTH
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 PREA
Abacavir sulfate - Ziagen ViiV Healthcare Company Medical (PDF - 4.2 M B) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 4.7 MB) PREA
Abatacept - Orencia Bristol-Myers Squibb Company

Medical (PDF - 259 KB)

Medical Addendum (PDF - 469 KB)

Clinical pharmacology (PDF - 2.3 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
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)

Medical (PDF - 199K KB)

Medical (PDF - 336KB)

DD Summary Review (PDF - 2.9 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 -3.6 MB) Statistical (PDF -1.6 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) PREA
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 -2.5 MB) Statistical (PDF -1.1 MB) PREA
Aliskiren - Tekturna Noden Pharma DAC CDTL (PDF - 310 KB) Clinical pharmacology (PDF -3.3 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
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 - 4.1 KB) None PREA
Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT  Neos Therapeutics, Inc. Medical (PDF - 470 KB) Clinical pharmacology (PDF -3.3 MB) None PREA
Amphetamine - Dyanavel XR Tris Pharma Medical (PDF - 1.8 MB) Clinical pharmacology (PDF -4.8 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
Aprepitant - Emend Merck Sharp & Dohme Corp. Medical (PDF - 5.7 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF -2.9 MB)
Clinical pharmacology (PDF -5  MB)

Clinical pharmacology addendum (PDF -424 KB)
Statistical (PDF -1.4 MB) PREA
Aprepitant - Emend Merck Sharp & Dohme Corp. Medical (PDF - 553 KB) Clinical pharmacology (PDF - 5 MB)

Addendum (PDF -105 KB)
Statistical (PDF -1.2MB) PREA
Aprepitant - Emend Merck Sharp & Dohme Corp.

Medical (PDF - 5 MB)

Medical Addendum (PDF -1.1 MB)

Medical DD memo (PDF - 2.9 MB)

Clinical pharmacology (PDF - 5 MB)

Addendum (PDF - 105 Azelastine hydKB)
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 -1MB) None PREA
Atazanavir - Reyataz Bristol-Myers Squibb Company Medical (PDF - 14.1MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -1.9MB) BOTH
Atazanavir - Reyataz  Bristol-Myers Squibb Company Medical (PDF - 1.6MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -3.9MB) BOTH
Atazanavir - Reyataz  Bristol-Myers Squibb Company Medical (PDF - 461 KB) Clinical pharmacology (PDF - 318 KB) S Statistical (PDF - 682 KB)

BOTH 

 

Atezolizumab - TECENTRIQ

Genentech, Inc. Medical (PDF - 1 MB) None None PREA

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 -702KB) Statistical (PDF -1.2MB) 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 -1.5MB) Statistical (PDF -959KB) PREA

Belumosudil - Rezurock

 

Kadmon Pharmaceuticals, LLC Medical (PDF - 7MB) Non 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
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 -1.2MB) Statistical (PDF - 374KB) 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 BOTH
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)

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 -564KB) 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 -610KB) BPCA
Carbinoxamine maleate - Karbinal ER Tris Pharma, Inc. Medical (PDF - 1.4MB) Clinical pharmacology (PDF - 500KB) 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
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
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) PREA
Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution Laboratorios SALVAT, S.A. Medical (PDF - 4MB) Clinical pharmacology (PDF -632KB) 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 -97KB) Statistical (PDF -896KB)

Addendum (PDF -157KB
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 - 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)

Statistical Addendum (PDF - 96 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 PREA
Decitabine - Dacogen  Eisai Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF -1MB) None BPCA
Deferasirox - Jadenu Novartis Pharmaceuticals Corporation Medical (PDF - 9 MB) Clinical pharmacology (PDF - 1.5MB) Statistical (PDF - 2MB) PREA
Deferasirox - Jadenu Novartis Pharmaceuticals Corporation

CDTL Review (PDF - 795 KB)

Medical (PDF - 843 KB)

None None PREA
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 -748KB) Clinical pharmacology (PDF -40KB) Statistical (PDF -479KB) BPCA
Dolutegravir - Tivicay ViiV Healthcare Medical (PDF -7.8MB) Clinical pharmacology (PDF -10.8MB) Statistical (PDF -4MB) PREA
Dolutegravir - Tivicay  ViiV Healthcare Medical (PDF -1.6MB)

CDTL Review (PDF -932KB)
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 -241KB) Clinical pharmacology (PDF -89KB) Statistical (PDF -131KB) 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
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 - Promacta  Novartis Pharmaceuticals Corporation Medical (PDF -3.5MB) Clinical pharmacology (PDF -1.2MB) 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) BPCA
Escitalopram oxalate - Lexapro Forest Laboratories, Inc. Medical (PDF - 218 KB) None None BPCA
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/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 PREA
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
addendum
 (PDF - 10 KB)

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 addendum (PDF -  166 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
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
Keppra XR - Levetiracetam UCB Pharma Medical (PDF - 3 MB) Clinical pharmacology (PDF - 8 MB) None BPCA
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 - 1.9 MB) PREA
Lubiprostone - Amitizia Sucampo Pharmaceuticals Inc. Medical (PDF - 11 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 1 MB) PREA
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 BOTH
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 - 425KB)
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 -499KB) 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 - 1.1KB) 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
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 BPCA
Mixed salts of a single-entity amphetamine product - Mydayis  Shire Development, LLC.

Medical (PDF - 6.8 MB)

Clinical pharmacology  (PDF -1.8KB) Statistical (PDF -987KB) PREA
Mixed salts of a single entity amphetamine product - Mydayis  Shire Development, LLC. Medical (PDF - 6.8 MB) None None BPCA
Mometasone furoate - Asmanex HFA Merck Sharp & Dohme Corp. Medical (PDF - 3 MB) Clinical pharmacology (PDF -1.5MB) 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 BPCA
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 - Narcan Nasal Spray  Adapt Pharma Operations Limited DD Summary Review(PDF -1.2MB)

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 - Naloxone Hydrochlorid Amphastar Pharmaceuticals, Inc

Medical (PDF - 3 MB)

CDDD Review (PDF - 637 KB)

Clinical pharmacology (PDF - 2 MB) 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 - 1MB) 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 - 469KB) PREA
Obiltoxaximab - Anthim Elusys Theraputics, Inc. Medical (PDF -18MB)

Addendum (PDF -249KB)
Clinical pharmacology (PDF -12MB)

Addendum (PDF -126KB)
Statistical (PDF - 9MB) PREA
Ocriplasmin- Jetrea ThromboGenics, Inc. Medical (PDF - 817KB) Clinical pharmacology (PDF - 117KB) Statistical (PDF - 760KB)  PREA
Olanzapine and fluoxetine hydrochloride - Symbyax Eli Lilly and Company Medical (PDF -1.3MB) Clinical pharmacology (PDF -1.2MB)

Addendum (PDF - 132KB)

Statistical (PDF - 953KB) PREA
Olopatadine - Pazeo Alcon Research LTD Medical (PDF -2.3MB) Clinical pharmacology (PDF -340KB) Statistical (PDF - 4.3KB) 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 NEW Genentech, Inc. Medical (PDF - 8 MB) None None PREA
Omeprazole magnesium - Prilosec  AstraZeneca Pharmaceuticals LP Medical (PDF - 908 KB) Clinical pharmacology (PDF -1.6MB) 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
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 - 184 KB)

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 NEW 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 - 767KB 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 -4.8MB) Clinical pharmacology (PDF -6MB) Statistical (PDF -1.2MB) PREA
Perampanel - Fycompa Eisai, Inc. Medical (PDF -2.9MB)
Medical (PDF -1.6MB)
Clinical pharmacology (PDF -4MB) Statistical (PDF -1.3MB) PREA
Perampanel - Fycompa Eisai Inc. Medical (PDF -2.6MB)

Medical  MTL (PDF -678KB)
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 NEW
 
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 - 1.2MB) Statistical (PDF - 252KB) PREA
Posaconazole - Noxafil Merck Medical (PDF - 602 KB) Clinical pharmacology (PDF -  645KB) None PREA
Potassium phosphate Fresenius Kabi USA, LLC Medical (PDF - 602 KB) 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 - Cyramz

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 NEW Gilead Sciences, Inc. CDTL (PDF - 4 MB) None None PREA
Reslizumab - Cinqair   Teva Respiratory, LLC Medical (PDF -5MB) Clinical pharmacology (PDF - 9 MB) Statistical (PDF - 2 MB) PREA
Rifapentin - Priftin Sanofi US Services Inc. Medical (PDF -10.1MB) 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
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 - 20KB)

CTDL Review (PDF - 1MB)

Medical (PDF - 670KB)

Medical (PDF - 667KB)
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) BOTH
Sapropterin dihydrochloride - Kuvan BioMarin Pharmaceutical Inc. Medical (PDF -3.6MB) Clinical pharmacology (PDF -2.5MB) None BPCA
Saquinavir mesylate - Invirase Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -1MB) BOTH

Sarecycline - Seysara

Allergan, Inc.  Medical (PDF -1MB)  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 -1.1MB)

Medical 2 (PDF -1.2MB)

Medical Secondary 1 (PDF -349KB)

Medical Secondary 2 (PDF -188KB)
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 - 745KB) Clinical pharmacology (PDF -  542KB) 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 - 6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF - 508KB) 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
Spinosad - Natroba ParaPRO, LLC Medical (PDF - 854KB) 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 K) None None PREA
Sofosbuvir and velpatasvir - Epclusa Gilead Sciences, Inc. Medical (PDF -  218 K) 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) PREA
Solifenacin succinate - VESIcare Astellas Pharma Global Development, Inc. Medical (PDF - 3MB)

CDTL (PDF - 1.1MB)
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 - 5.1MB) 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 - 859KB) PREA
Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason  Bracco Diagnostics, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF -843KB) 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 -1.8MB) 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
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 BPCA
Tenofovir alafenamide - Vemlidy Gilead Sciences, Inc Medical (PDF - 2 MB) Clinical pharmacology (PDF - 3 MB) Statistical (PDF - 624 KB) 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 - 3.3MB)

Clinical (PDF - 3.4MB)

Clinical pharmacology (PDF - 1.5MB) Statistical (PDF - 410KB) BOTH
Tetracaine hydrochloride - None Alcon Research, Ltd. DD Medical Summary  (PDF -1.8MB)

Medical (PDF -1.4MB)
Clinical pharmacology (PDF - 158KB) Statistical (PDF - 2.3MB) PREA
Tetracaine HCl and Oxymetazoline HCl - Kovanaze  St. Renatus, LLC Medical (PDF - 11.8MB) Clinical pharmacology (PDF - 11.6MB) Statistical (PDF - 2.4MB) 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 - 418KB
Clinical pharmacology (PDF - 5.9MB) Statistical (PDF - 1.3MB)

Statistical Addendum (PDF -327 KB)
PREA
Tiotropium bromide - Spiriva Respimat  Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -  4.8MB) Clinical pharmacology (PDF - 2MB) Statistical (PDF - 432K B) BOTH
Tobramycin 300 mg/4mL inhalation solution - Bethkis Cornerstone Therapeutics Medical (PDF - 5.4MB) Clinical pharmacology (PDF - 78KB) 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
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 - 2.5 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 - Multrys  American Regent, Inc. Medical (PDF - 321 MB) 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
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
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
Zepatier (elbasvir and grazoprevir)  Merck Sharpe & Dohme Corp Medical (PDF - 838 KB) Clinical Pharmacology (PDF - 272 KB)   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 -4.5MB) None Statistical (PDF -2.9MB) PREA

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

 

 

 
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