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  1. Development & Approval Process (Drugs)

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

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

 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 BPCA and pediatric assessments conducted under PREA.

Total Number of Products Studied under BPCA = 49
Total Number of Products Studied under PREA = 226
Total Number of Products Studied under Both = 12

Drug Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both
Abacavir and Lamivudine - Epzicom ViiV Healthcare Company Medical (PDF - 2.8 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 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 BPCA
AbobotulinumtoxinA - Dysport Ipsen Bipharm Limited CDTL Review (PDF - 2 MB)

Medical (PDF - 3 MB)
None Statistical (PDF -2 MB) PREA
Acetaminophen - Ofirmev MallInc.krodt, Inc. Medical (PDF - 1.3 MB) Clinical pharmacology (PDF - 5.4 MB) Statistical (PDF -378 KB) PREA
Acyclovir 5%, hydrocortisone 1% - Xerese   Valeant International Bermuda Medical (PDF -885 KB) None None PREA
Aacyclovir sodium- Zovirax  GlaxoSmithKline, LLC None Clinical pharmacology (PDF - 3 MB) None  PREA
Adalimumab-atto - Amjevita Amgen Inc.

CDTL Review (PDF - 4.3 MB)

Medical (PDF - 199K B)

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 - Humira AbbVie,Inc. Medical (PDF - 2.2 MB) None None PREA
Adapalene and benzoyl peroxide - Epiduo Galderma Laboratories, LP Medical (PDF - 2.2 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
Albuterol sulfate - ProAir RespiClick Teva Pharmaceutical Products R. & D., Inc. Medical (PDF - 3 MB) Clinical pharmacology (PDF -4 MB) Statistical (PDF -2.2 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) BPCA
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
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 -105KB)
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 - 5MB)

Addendum (PDF - 105KB)
Statistical (PDF -1.2MB) PREA
Aripiprazole - Abilify Otsuka Medical (PDF - 2.4MB) None Statistical (PDF -409KB) PREA
Asenapine - Saphris Forest Laboratories, Inc. Medical (PDF - 5.4MB)

Medical (PDF - 4MB)
Clinical pharmacology (PDF -3.8MB) Statistical (PDF -3MB) BPCA
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 

 

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 PREA
Azelastine hydrochloride and Fluticasone propionate - Dymista Meda Pharmaceuticals, Inc. Medical (PDF - 2.9MB) None Statistical (PDF -2.1MB) BPCA

Baloxavir marboxil - Xofluza

Shionogi, Incorporated

 

CDTL (PDF - 869 KB)

Medical (PDF - 414 KB)

Clinical pharmacology (PDF -  3 MB) Statistical (PDF -  2 MB)   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 - 3.7MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -959KB) PREA
Belimumab - Benlysta  Human Genome Sciences Medical (PDF - 6 MB) None None PREA
Benralizumab - Fasenra AstraZeneca AB Medical (PDF - 1.7 MB) Clinical pharmacology (PDF -7 MB) Statistical (PDF - 2 MB) PREA
Bimatoprost ophthalmic solution, 0.03% - Latisse Allergan, Inc. DD Summary Review (PDF - 966KB)

CDTL Review (PDF - 3.4MB)

Medical (PDF - 1.6MB)
None Statistical (PDF -946KB)

Statistical Addendum (PDF - 127KB)
PREA

Blinatumomab - Blincyto

 

 Amgen, Inc. Medical (PDF - 9 MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA
Bortezomib - Velcade Millennium Pharmaceuticals, Inc. Medical (PDF - 3.5MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -374KB) BPCA
Budesonide - Entocort EC Elan Pharma International Medical (PDF - 2.9MB) Clinical pharmacology (PDF -2.8MB) Clinical pharmacology (PDF -2.8MB) PREA
Brimonidine tartrate - Lumify Bausch + Lomb CDTL Review (PDF - 2.5 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

 

Budesonide/formoterol fumarate dehydrate -  Symbicort AstraZeneca Pharmaceuticals, LP Medical (PDF - 3.4 MB) Clinical pharmacology (PDF - 1.2 MB) Statistical (PDF - 2.5 MB) 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
Calcipotriene - SORILUX Foam  Mayne Pharma LLC Medical (PDF - 525 KB) None 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
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
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
Ceftaroline fosamil - Teflaro  Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC Medical (PDF - 10.9MB)

Medical CTDL (PDF -1.5MB)
Clinical pharmacology (PDF - 3MB) Statistical (PDF -1.2MB) BPCA
Ceftazidime and Avibactam - Avycaz

 
Allergan Sales, LLC Medical (PDF - 5 MB) None None PREA
Cetirizine ophthalmic solution - Zerviate Nicox Ophthalmics, Inc.

Medical Resubmission (PDF - 231 KB)

Medical (PDF - 4.9 MB)

Clinical pharmacology (PDF - 279 KB) Statistical (PDF - 580 KB) BOTH
Ciclesonide - Zetonna Takeda GmbH

Medical (PDF - 5MB)

Clinical pharmacology (PDF -1.3MB) Statistical (PDF -674KB) 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) None None BPCA 
Clonidine - Kapvay Concordia Pharms Inc. Medical (PDF - 2.6MB) None Statistical (PDF -2MB) PREA
Crisaborole Ointment, 2% - Eucrisa Anacor Pharmaceuticals Inc. CDTL Review (PDF - 2MB)

Medical (PDF - 12MB)
Clinical pharmacology (PDF - 7MB) Statistical (PDF - 1MB) PREA
Cysteamine bitartrate - Procysbi Raptor Pharmaceuticals, Inc. Medical (PDF -12MB) Clinical pharmacology (PDF -1.3MB)

Clinical pharmacology addendum (PDF -420KB)
None BPCA
Cysteamine bitartrate - Procysbi Horizon Pharma USA, Inc.
 
Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1.2MB) Statistical (PDF - 1MB) BPCA
Dalteparin sodium - Fragmin NEW Pharmacia & Upjohn, a subsidiary of Pfizer Inc. Medical (PDF - 3.5 MB) None None PREA
Dapsone - Aczone Allergan, Inc. Medical (PDF - 3.5 MB) Clinical pharmacology (PDF -  2.6 MB) Statistical (PDF -1.3 MB) 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 
Darbepoetin alfa - Aranesp Amgen Inc. Medical (PDF -1.6MB) None Statistical (PDF -280KB) BPCA
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 
Decitabine - Dacogen  Eisai Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -1MB) None BPCA
Deferasirox - Exjade Novartis Pharmaceuticals Corporation Medical (PDF -9MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -2MB) 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
Dexlansoprazole - Dexilant Takeda Pharmaceuticals USA Inc. CDTL Review (PDF-661KB)

Medical (PDF-5MB)
Clinical pharmacology (PDF-1MB) Statistical (PDF-50KB) PREA
Dexmedtomidine hydrochloride - Precedex Hospira Medical (PDF -5MB) Clinical pharmacology (PDF -3.8MB) Statistical (PDF -1MB) BPCA

Diclofenac epolamine topical system 1.3% - Flector 

IBSA Institut Biochimique SA

Medical (PDF - 1 MB) 

None 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
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
Duloxetine - Cymbalta Eli Lilly and Company, Inc. Medical (PDF -2.2MB) Clinical pharmacology (PDF -197KB) Statistical (PDF -2.8MB) PREA
Duloxetine hydrochloride - Cymbalta Eli Lilly and Company Medical (PDF -8MB) Clinical pharmacology (PDF -959KB) Statistical (PDF -665KB) BPCA
Econazole nitrate - Ecoza AmDerma Pharmaceuticals, LLC Medical (PDF -2MB) Clinical pharmacology (PDF -2.5MB) Statistical (PDF -422KB) 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 BPCA
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  PREA
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 PREA
Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild Gilead Sciences, Inc. CTDL Review (PDF -359KB) Clinical pharmacology (PDF - 462KB) None PREA
Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey Gilead Sciences, Inc. Medical (PDF -310KB)

CTDL Review (PDF -578KB)
Clinical pharmacology (PDF -5MB)

Clinical pharmacology addendum (PDF -297KB)
None PREA
Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy Gilead Sciences, Inc. Medical (PDF -1.27MB)

Addendum (PDF -572KB)
Clinical pharmacology (PDF -7.6MB) Statistical (PDF -1.9MB) PREA
Emtricitabine and tenofovir alafenamide - Descovy Gilead Sciences, Inc. Medical (PDF - 642 KB) Clinical pharmacology (PDF -145KB) None PREA
Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera Gilead Sciences, Inc. Medical (PDF -1MB) Clinical pharmacology (PDF -145KB) 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 -3.4MB) Clinical pharmacology (PDF -3MB) Statistical (PDF -660KB) BPCA
Erlotinib - Tarceva OSI Pharmaceuticals, LLC Medical (PDF -6.2MB) Clinical pharmacology (PDF -2.2MB) None BPCA
Epinephrine - Auvi-Q Kaleo, Inc. Medical (PDF - 1.8 MB) None None PREA
Escitalopram oxalate - Lexapro Forest Laboratories, Inc. Medical (PDF -218KB) None None BPCA
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 BPCA
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-szzs - Erelzi Sandoz Inc. Medical (PDF - 1.7 MB) Clinical pharmacology (PDF - 4.7 MB) Statistical (PDF - 432 KB) PREA
Etravirine - Intelence Janssen Products, LP Medical (PDF -1.4MB) Clinical pharmacology (PDF -1.7MB) None PREA
Etravirine - Intelence Janssen Products, LP Medical (PDF -1 MB) Clinical pharmacology (PDF - 896 KB) None BPCA
Everolimus tablets for oral suspension - Afinitor Disperz Novartis Pharmaceuticals Corporation Medical (PDF -10MB) Clinical pharmacology (PDF -2MB) 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) BPCA
Fingolimod - Gilenya  Novartis Pharmaceuticals Corporation

CDTL Review (PDF - 2 MB)

Medical (PDF - 3.8 MB)

Clinical pharmacology (PDF -2MB) Statistical (PDF -3.2MB) 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 propionate Lotion - Cutivate Fougera Pharmaceuticals Inc. Medical (PDF -3MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -317MB) PREA
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/salmeterol - AirDuo Teva Pharmaceutical Industries Ltd. Medical (PDF -10 MB) Clinical pharmacology (PDF - 4.3 MB) Statistical (PDF -1.2 KB) PREA
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) BPCA
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 PREA
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
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
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 PREA
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
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
Guanfacine - Intuniv Shire Medical (PDF -2.3MB)

CTDL Review (PDF -2.56KB)
Clinical pharmacology (PDF -352KB) Statistical (PDF -708KB) Both
Guanfacine - Intuniv Shire Medical (PDF -3MB) Clinical pharmacology (PDF -667KB) Statistical (PDF -3MB) PREA
Ibuprofen - Caldolor Cumberland Pharmaceuticals, Inc. DD Summary Review (PDF -669KB)

Medical (PDF -3MB)
 
Clinical pharmacology (PDF -3.7MB) Statistical (PDF -378KB) PREA

Indocyanine green for Injection - Spy Agent Green

 

Novadaq Technologies ULC Medical (PDF - 4 MB)   None None PREA

Indocyanine green for Injection - Spy Agent Green

 

Novadaq Technologies ULC 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 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
Iodixanol - Visipaque

GE HealthCare Inc.

CDTL Review (PDF -  2.4 MB)

Medical (PDF - 1.9  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  5.5 MB) Clinical pharmacology (PDF - 1.6 MB) None PREA
Iron Sucrose Injection, USP - Venofer Luitpold Pharmaceuticals, Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF - 114 KB) Statistical (PDF - 576 KB) PREA
Ivabradine - Corlanor  Amgen Inc.

CDTL (PDF - 3 MB)

Medical (PDF - 4 MB)

Clinical pharmacology (PDF - 4 MB) Statistical (PDF - 51 KB) BPCA
Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage  Jubilant DraxImage, Inc
 
Medical (PDF - 2 MB) None Statistical (PDF -3 76KB) PREA
Lacosamide - Vimpat  UCB, Inc.

CDTL Review (PDF - 371 KB)

Medical (PDF - 915 KB)

Clinical pharmacology (PDF - 2 MB) None

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
Ledipasvir-sofosbuvir - Harvoni Gilead Sciences, Inc. Medical and CDTL (PDF - 1.5 MB) Clinical pharmacology (PDF - 539 KB) Statistical (PDF - 205 KB)  
Levalbuterol hydrochloride - Xopenex Oak Pharmaceuticals Medical (PDF -8.3 MB) Clinical pharmacology (PDF - 3.9 MB) Statistical (PDF - 2 MB) PREA
Levalbuterol tartrate - Xopenex HFA Sunovion Pharmaceuticals Inc. Medical (PDF -3.9 MB) Clinical pharmacology (PDF - 1.2 MB) Statistical (PDF 1.3 MB) PREA
Levetiracetam - Keppra Extended Release Tablets UCB, Inc. DD Summary Review (PDF - 202KB)

CDTL Review (PDF - 371 KB)

Medical (PDF - 327KB)
Clinical pharmacology (PDF - 1.2 MB) None PREA
Levonorgestrel - Liletta Medicines360 Medical (PDF - 8.8 MB) Clinical pharmacology (PDF - 1M B)

Clinical pharmacology (PDF - 2.4 MB)
Statistical (PDF - 1.5 MB) PREA
Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette Teva Branded Pharmaceutical Products R&D, Inc. Medical (PDF -6MB) 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
Levothyroxine sodium oral solution - Tirosint-SOL Cromsource, Inc.

CDTL Review (PDF - 461 KB)

Medical (PDF - 2.8 MB)

Clinical pharmacology (PDF - 1.8 MB) None PREA
Llisdexamfetamine dimesylate - Vyvanse  Shire Development, LLC Medical (PDF -  218 KB) Clinical pharmacology (PDF - 1 MB) None PREA
Lisdexamfetamine mesylate - Vyvanse Shire Medical (PDF -  2.4 MB) None Statistical (PDF - 1 MB) 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) PREA
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 -  6 MB)
Clinical pharmacology (PDF - 2 MB) Statistical (PDF -  368 KB)
Statistical (PDF - 254 KB)
PREA
Maraviroc - Selzentry Viiv Healthcare Medical (PDF - 1.0 MB) Clinical pharmacology (PDF - 2.8 MB) None PREA
Memantine hydrochloride - Namenda XR Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) Medical (PDF - 2.1 MB) Clinical pharmacology (PDF - 956 KB) Statistical (PDF - 1.1 MB) BPCA
Mepolizumab - Nucala GlaxoSmithKline LLC Medical (PDF - 8 MB) Clinical pharmacology (PDF - 6 MB)

Clinical pharmacology addendum (PDF -425KB)
Statistical (PDF - 1.4 MB) PREA
Mesalamine - Asacol HD Warner Chilcott Medical (PDF - 6MB) Clinical pharmacology (PDF - 3.2 MB)

Clinical pharmacology (PDF - 518 KB)
Statistical (PDF -499KB) PREA
Mesalamine  - Canasa Forest Laboratories Medical (PDF - 6 MB) Clinical pharmacology (PDF - 251KB) Statistical (PDF - 344 KB) PREA
Mesalamine - Delzicol Warner Chilcott LLC Medical (PDF - 707 KB)

Medical Addendum(PDF - 495 KB)
Clinical pharmacology (PDF -116KB) None PREA
Mesalamine - Delzicol  Warner Chilcott (US), LLC Medical (PDF - 4.7 MB) Clinical pharmacology (PDF - 729 KB) Statistical (PDF - 1.1KB) 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 - 2.6 MB) Statistical (PDF - 1.4 MB) PREA

Methylphenidate hydrochloride extended-release - Aptensio XR

Rhodes Pharmaceuticals L.P. Medical (PDF - 2.3 MB) Clinical pharmacology (PDF - 3.6M B) Statistical (PDF - 1.1 MB)
Statistical (PDF - 629 KB)
PREA
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 -1.3MB)

Medical (PDF - 4.8 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 - 4.8 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 NEW Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited Medical (PDF - 799 KB) Clinical pharmacology (PDF - 978 KB) None PREA
Metronidazole vaginal gel 1.3% - Nuvessa Chemo Research SL Medical (PDF - 1.2 MB) Clinical pharmacology (PDF - 70 KB) Statistical (PDF - 127 KB) PREA 
Micafungin sodium - Mycamine Astellas Pharma US, Inc. Medical (PDF - 2.2 MB)

Clinical pharmacology (PDF - 4.4MB)

Statistical (PDF -987KB) 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
Mometasone furoate - Asmanex HFA Merck Sharp & Dohme Corp. Medical (PDF -2.7MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -603KB) PREA
Mometasone furoate - Asmanex HFA Merck Sharp & Dohm Corp Medical (PDF-1MB) None None PREA
Mometasone furoate and formoterol fumarate - Dulera Schering-Plough Medical (PDF-1MB) None None PREA

Moxifloxacin - Avelox

Bayer Pharmaceuticals Medical (PDF- 905KB) Clinical pharmacology (PDF -1.8MB) Statistical (PDF - 760KB) PREA
Moxifloxacin ophthalmic solution - Vigamox Alcon Pharmaceuticals, Ltd. Medical (PDF - 434 KB)

DD Summary Review (PDF- 118 KB)
None None BPCA
Naftifine hydrochloride - Naftin Merz Pharmaceuticals, LLC Medical (PDF -488KB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF - 188KB) PREA
Naftifine hydrochloride - Naftin Cream, 2% Merz Pharmaceuticals, LLC Medical (PDF - 1.2MB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF - 822KB)  PREA
Naloxone hydrochloride - Narcan Nasal Spray Adapt Pharma Operations Limited DD Summary Review(PDF -1.2MB)

CTDL Review (PDF -3MB)
Clinical pharmacology (PDF -1.5MB) None PREA
Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM Bayer HealthCare, LLC – Consumer Care Medical (PDF -1MB) Clinical pharmacology (PDF -1.7MB) Statistical (PDF -1.3MB) PREA
Naproxen and esomeprazole magnesium - Vimovo  Horizon Pharma Inc. Medical (PDF - 3.8 MB) Clinical pharmacology (PDF -2.3 MB) None PREA
Neostigmine methylsulfate - Bloxiverz Eclat Pharmaceuticals, LLC Medical (PDF -7.7MB) Clinical pharmacology (PDF -2MB) None PREA
Nevirapine - Viramune XR Boehringer Ingelheim Pharmaceuticals, Inc. Medical (PDF -2MB) Clinical pharmacology (PDF -446KB) Statistical (PDF - 723KB) PREA
Nilotinib -  Tasigna   Sponsor: Novartis Pharmaceuticals Corporation Medical (PDF - 1.2 MB) Clinical pharmacology (PDF - 1.6 MB) Statistical (PDF - 124 KB) BPCA
Nitisinone - NITYR Cycle Pharmaceuticals Ltd. Medical (PDF - 358 KB) Clinical pharmacology (PDF - 3.6 MB) 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) BPCA
Omalizumab - Xolair Genentech Medical (PDF -6MB) Clinical pharmacology (PDF -1.3MB) Statistical (PDF - 2MB) PREA
Omalizumab - Xolair Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF-4MB) Clinical pharmacology (PDF -1MB) Statistical (PDF-1 MB)  PREA

Omalizumab - Xolair

 

Genentech, Inc. and Novartis Pharmaceuticals Corp. Medical (PDF - 5MB) None None  PREA
Omeprazole magnesium - Prilosec  AstraZeneca Pharmaceuticals LP Medical (PDF -908KB) Clinical pharmacology (PDF -1.6MB) None PREA

OnabotulinumtoxinA - Botox

Allergan 

CDTL (PDF - 403 KB)
 

Medical (PDF - 1 MB)


 None
Statistical (PDF - 173 KB) PREA 
Oxcarbazepine - Oxtellar XR Supernus Pharmaceuticals, Inc. Medical (PDF -5MB) Clinical pharmacology (PDF -7MB) Statistical (PDF - 482KB) PREA
Oxycodone hydrochloride - Oxycontin Purdue Pharma L.P. Medical (PDF -17.6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF - 678KB) BPCA
Ozenoxacin - Xepi  Ferrer Internacional S.A. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 1 MB) Statistical (PDF - 524 KB) PREA
Palifermin - Kepivance Quintiles, Inc. Medical (PDF -280KB) Clinical pharmacology (PDF -726KB) None PREA
Palonosetron hydrochloride - Aloxi Helsinn Healthcare SA Medical (PDF -15MB)

Medical (PDF -2MB)
Clinical pharmacology (PDF -2.3MB) Statistical (PDF - 771KB) BPCA
Pancrelipase - Creon AbbVie Inc. Medical (PDF -566KB) None None PREA
Pancrelipase - Pancreaze  Janssen Pharmaceuticals, Inc. Medical (PDF -142KB) None None PREA
Pancrelipase - Pertzye Digestive Care, Inc. Medical (PDF - 1MB) None None PREA
Pancrelipase - Zenpep Aptalis Pharma Limited. Medical (PDF -587KB) None None PREA
Paricalcitol - Zemplar AbbVie Inc. Medical (PDF - 3.0MB)

CDTL (PDF - 1.1MB)
Clinical pharmacology (PDF - 1.9MB) Statistical (PDF - 427KB) 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 
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
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 
Phentolamine mesylate - OraVerse  Septodont Holding Sas Medical (PDF -2.7MB) None Statistical (PDF -1.4MB) PREA
Phenylephrine hydrochloride ophthalmic solution Paragon BioTeck, Inc. Medical (PDF - 1MB) Clinical pharmacology (PDF - 95KB) Statistical (PDF -1MB) PREA
Phenylephrine and ketorolac - Omidria  Omeros Corporation CDTL (PDF - 1 MB)
Medical (PDF - 4 MB)
None Statistical (PDF - 816 KB) BPCA
Posaconazole - Noxafil Merck Sharp & Dohme Corp. Medical (PDF - 3MB) Clinical pharmacology (PDF - 1.2MB) Statistical (PDF - 252KB) PREA
Posaconazole - Noxafil Merck Medical (PDF - 602KB) Clinical pharmacology (PDF -  645KB) None PREA
Prasugrel - Effient Eli Lilly and Company Medical (PDF - 2MB) Clinical pharmacology (PDF - 911KB) Statistical (PDF -290KB) BPCA
Pregabalin - Lyrica Pfizer Medical (PDF -  3.8MB) Clinical pharmacology (PDF - 5.9KB) Statistical (PDF - 825KB) PREA
Pregabalin - Lyrica  PF PRISM CV Medical and Statistical (PDF -  1.2 MB) Clinical pharmacology (PDF - 1.3 MB) Medical and Statistical (PDF -  1.2 MB) PREA 
Quetiapine fumarate - Seroquel and Seroquel XR AstraZeneca Pharmaceuticals LP

CTDL Review (PDF -1MB)

Medical (PDF - 3MB)

Clinical pharmacology(PDF -1.8MB)

Clinical pharmacology (PDF -739KB)

Statistical (PDF -785KB) PREA
Rabeprazole sodium - AcipHex Sprinkle Eisa Inc. Medical (PDF - 3MB) Clinical pharmacology (PDF - 5MB) Statistical (PDF 185KB) BPCA
Raltegravir - Isentress Merck Sharp Dohme Corp Medical (PDF -1MB) Clinical pharmacology  (PDF -2.4MB) None PREA
Raltegravir - Isentress Merck Sharp Dohme Corp CDTL Review (PDF - 4.5 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 PREA
Reslizumab - Cinqair   Teva Respiratory, LLC Medical (PDF -5MB) Clinical pharmacology (PDF -9MB) Statistical (PDF -1.6MB) PREA
Rifapentin - Priftin Sanofi US Services Inc. Medical (PDF -10.1MB) Clinical pharmacology (PDF -5.1MB) Statistical (PDF -3.1MB) PREA
Rilpivirine - Edurant  Janssen Products L.P. Medical (PDF -2.3MB) Clinical pharmacology (PDF -138KB) None PREA
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
Rufinamide - Banzel Eisai Inc. Medical (PDF -9.4MB) Clinical pharmacology (PDF -3MB) None BPCA
Ruxolitinib - Jakafi Incyte Corporation
 
Medical (PDF - 685 KB) Clinical pharmacology (PDF - 533 KB) None BPCA
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) PREA

Sarecycline - Seysara  

 

Allergan, Inc. 
Medical (PDF -1MB) 
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  
Segesterone acetate and ethinyl estradiol vaginal systems - Annovera  The Population Council, Inc. Medical (PDF -  5 MB) None None PREA
Sevelamer Carbonate - Renvela Genzyme/Sanofi Medical (PDF - 745KB) Clinical pharmacology (PDF -  542KB) Statistical (PDF - 541KB) PREA
Sildenafil - Revatio Pfizer, Inc. Medical (PDF - 6MB) Clinical pharmacology (PDF -2MB) Statistical (PDF -508KB) BOTH
Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik Ferring Pharmaceuticals Inc. Medical (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
Solifenacin succinate - VESIcare Astellas Pharma Global Development, Inc. Medical (PDF - 2 MB) Clinical pharmacology (PDF - 933KB) Statistical (PDF - 960 KB) 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 - 1.1MB)
Clinical pharmacology (PDF - 1MB) Statistical (PDF - 859KB) PREA
Sumatriptan/Naproxen - Treximet Pernix Therapeutics Medical (PDF -1.8MB) Clinical pharmacology (PDF -2.8MB) Statistical (PDF -843KB)

Statistical Addendum (PDF -702KB)
BPCA
Sunitinib malate - Sutent  C.P. Pharmaceuticals International C.V. CDTL (PDF - 680 KB) None  None PREA
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 - 1.4MB) None BPCA
Tavaborole - Kerydin  Anacor Pharmaceuticals, Inc. Multi-disciplinary review (PDF - 2.5 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 BPCA
Teduglutide - Gattex NEW Shire-NPS Pharmaceuticals, Inc. Medical (PDF - 9 MB) None None BOTH
Tenofovir disoproxil fumarate - Viread Gilead Sciences Medical (PDF - 2.4MB) Clinical pharmacology (PDF - 1.4MB) Statistical (PDF - 1.4MB) PREA
Tenofovir disoproxil fumarate - Viread Gilead Sciences   CDTL (PDF - 873 KB) Clinical pharmacology (PDF - 180 KB) Statistical (PDF - 149 KB)  PREA
Tenofovir disoproxil fumarate - Viread Gilead Sciences CDTL (PDF - 349 KB) Clinical pharmacology (PDF -  1.7 MB) Statistical (PDF -  148 KB)  PREA
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
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) PREA
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 PREA
Topiramate - Topamax Janssen Pharmaceuticals, Inc. Medical (PDF - 8.6MB) None Statistical (PDF - 881KB) PREA
Trabectedin - Yondelis Janssen Products, LP Medical (PDF - 2.5 MB) Clinical pharmacology  (PDF -  683 KB) None BPCA
Tranexamic acid - Lysteda Ferring Pharmaceuticals, Inc. None Clinical pharmacology (PDF - 1.2MB) None PREA
Tretinoin lotion - Altreno    Dow Pharmaceutical Sciences, Inc. Medical (PDF -  3 MB) None None PREA
Valganciclovir hydrochloride - Valcyte Roche Palo Alto LLC c/o Genentech, Inc.orporated Medical (PDF -2 .7MB) Clinical pharmacology (PDF - 6MB) None PREA

Varenicline - Chantix

 

 

PF Prism C V   None Clinical pharmacology (PDF -  3 MB) None PREA 
Ustekinumab - Stelara Janssen Biotech Inc.

CDTL (PDF - 593 KB)

Medical (PDF - 5.2 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
Voriconazole - Vfend PF PRISM C.V. Medical (PDF -  2.5 MB) Clinical Pharmacology (PDF - 1.4 MB) Statistical (PDF -  439 KB) 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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