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 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 – 527 KB) 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 – 553KB) 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) 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 NEW 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 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) BOTH 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 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) BOTH 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 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 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) BPCA Deferasirox – Jadenu NEW Novartis Pharmaceuticals Corporation CDTL Review (PDF- 843 KB)

Medical (PDF- 795 KB)

Clinical pharmacology (PDF – 180 KB) None BPCA 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 Difluprednate ophthalmic emulsion – Durezol Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd Medical (PDF -748KB) Clinical pharmacology (PDF -40KB) Statistical (PDF -479KB) BPCA Doxycycline hyclate – LymePak Chartwell Pharma NDA B2 Holdings, LLC
  Medical (PDF – 1 MB) None None PREA 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 Dupilumab – Dupixent Regeneron Pharmaceuticals Medical (PDF – 6MB) None None PREA 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 – 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 Epinephrine – Auvi-Q Kaleo, Inc. Medical (PDF – 1.8 MB) None None PREA Erlotinib – Tarceva OSI Pharmaceuticals, LLC Medical (PDF -6.2 MB) Clinical pharmacology (PDF -2.2MB) None BPCA Escitalopram oxalate – Lexapro Forest Laboratories, Inc. Medical (PDF -218KB) 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 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 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 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) BOTH 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 BPCA Glycopyrronium – Qbrexza  Dermira, Inc.
  Medical (PDF –  6 MB) None None PREA Golimumab – Simponi Janssen Biotech, Inc.

Medical (PDF – 3.1 MB)

CTDL Review (PDF – 480 KB)

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 NEW 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 BPCA Iron Sucrose Injection, USP – Venofer Luitpold Pharmaceuticals, Inc. Medical (PDF -2 MB) Clinical pharmacology (PDF – 114 KB) Statistical (PDF – 576 KB) PREA 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 KB) 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) PREA 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 Loteprednol –  Lotemax  Bausch & Lonb Inc.

Medical (PDF –  318 KB)

Medical (PDF –  218 KB)

None Statistical (PDF – 3 MB) 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 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 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 Lurasidone hydrochloride – Latuda NEW Sunovion Pharmaceuticals, Inc.

CDTL (PDF – 461 KB) 

Medical (PDF – 1 MB)

Clinical pharmacology (PDF – 403 KB) Statistical (PDF – 403 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 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 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 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 oxybate – Xyrem  Jazz Pharmaceuticals Medical (PDF – 7 MB) Clinical pharmacology (PDF – 6 MB) Statistical (PDF – 365 KB) BPCA 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) BPCA 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 Tadalafil – Cialis Eli Lilly and Company Medical (PDF – 1 MB) Clinical pharmacology (PDF – 1.4MB) None BPCA

Tacrolimus – Astagraf XL NEW

Astellas Pharma US, Inc. Medical (PDF – 749 KB) None None PREA Tavaborole – Kerydin  Anacor Pharmaceuticals, Inc. Multi-disciplinary review (PDF – 2.5 MB) None None BPCA 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 Tenofovir disoproxil fumarate – Viread Gilead Sciences Medical (PDF – 2.4MB) Clinical pharmacology (PDF – 1.4MB) Statistical (PDF – 1.4MB) PREA Tenofovir disoproxil fumarate – Viread NEW Gilead Sciences CDTL (PDF – 349 KB) Clinical pharmacology (PDF – 180 KB) 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 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

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm316937.htm

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