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

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

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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)

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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)

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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

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The Midwest Battles Historic Floods In The Aftermath Of ‘Bomb Cyclone’

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Tom Wilke, his son Chad, and Nick Kenny launch a boat into the swollen waters of the Elkhorn River to check on Witke’s flooded property, in Norfolk, Neb., on Friday, March 15. Nati Harnik/AP hide caption

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Nati Harnik/AP

Tom Wilke, his son Chad, and Nick Kenny launch a boat into the swollen waters of the Elkhorn River to check on Witke’s flooded property, in Norfolk, Neb., on Friday, March 15.

Nati Harnik/AP

It’s the worst flooding parts of the Midwest have seen in decades, where several states are battling the aftermath of a powerful “bomb cyclone” which swept through the region last week, bringing blizzard conditions, hurricane-like winds, snow and heavy rain.

The powerful storm pushed some waterways, including the Missouri River, to record levels in South Dakota, Iowa and Minnesota.

Marc Chenard, a meteorologist with the National Weather Service, told NPR many areas will remain water-logged for days.

“All the rivers respond differently, have different time scales that they flood and then recede. A lot of the rivers are going to remain in flood into the weekend, and some into next week,” Chenard said. “Eventually as we head into next week, we should see more and more of the rivers start to recede below flood stage.”

Iowa, Wisconsin and Nebraska have all declared states of emergencies.

As rivers spill over their banks and through local communities, the rising waters are setting records.

In Nebraska, Gov. Pete Ricketts said nearly every part of the state is experiencing historic flooding.

Nebraska has deployed helicopters to assist in rescuing those trapped by the high waters, and boats for travel across washed out roads. CNN reported that some people who were rescued suffered from hypothermia, and had to be transported to the hospital.

The Omaha-Valley Weather Service office said a levee was breached in Nebraska’s Dodge County. “This is an extremely dangerous and life-threatening situation,” the weather service warned. “Do not attempt to travel unless you are fleeing an area subject to flooding or under an evacuation order.”

With flood waters rising, officials were monitoring for damage at the Cooper Nuclear Station, south of Omaha, which serves about half a million customers. Mark Becker, spokesperson for the Nebraska Public Power District told NPR the plant will continue operating for the foreseeable future. “If we get to the next threshold, the plant would go to a shutdown,” Becker said.

“A week ago, my backyard had a foot of snow in it. It’s warmed up. The ground is frozen still. The snow is melting, and we’ve had some torrential rains, and that’s created torrential flooding,” Becker told NPR.

In Wisconsin, Governor Tony Evers said flooding was impacting “homes, businesses, and cities and towns” across the state.

Lori Getter of the Wisconsin Emergency Management spoke with NPR. “We’re trying to get a handle on the situation with the flooding across the state, but two days ago, and even yesterday, we were evacuating people because of the rising waters,” Getter said.

A bomb cyclone occurs when there is a rapid drop in atmospheric pressure. The massive storm moved into Canada on Friday.

Provided By NPR

Bay Area’s High Cost Of Living Squeezes Restaurant Workers, Chefs And Owners

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Every morning at around 5 a.m., Armando Ibarra wakes up in the back of his van. He has been living there for the past couple of years. On his dashboard rests a holy candle. A rosary hangs from the rearview mirror.

Ibarra walks over to his job at a chain hotel near San Francisco’s airport. He says that at least he can wash up there. “I take a shower, drink my coffee, smoke a cigarette and ready to work.”

Armando Ibarra, a hotel restaurant worker in San Francisco, lives out of his van to save money — and to avoid an hours-long commute from San Jose, Calif. A holy candle rests on his dashboard; a rosary hangs from the rearview mirror. Jasmine Garsd/NPR hide caption

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Jasmine Garsd/NPR

Armando Ibarra, a hotel restaurant worker in San Francisco, lives out of his van to save money — and to avoid an hours-long commute from San Jose, Calif. A holy candle rests on his dashboard; a rosary hangs from the rearview mirror.

Jasmine Garsd/NPR

The hotel restaurant where Ibarra works as a food runner boasts creative, artisanal and healthy meals. People in the San Francisco Bay Area are known for being foodies (the city now has the most Michelin three-star restaurants in the U.S.).

But behind kitchen doors, tension has been stewing for years: Service-industry workers like Ibarra say they can no longer afford to live in the Bay Area on their wages. And restaurant owners say the high cost of living has made it hard to retain staff and even to stay in business.

The Bay Area is notoriously expensive. As the tech industry grows, rents have soared. A one-bedroom apartment costs well over $3,000 a month. The minimum wage just went up to $15 an hour, but the cost of living also keeps rising.

Ibarra makes around $15 an hour. He used to commute from neighboring San Jose, one of the most expensive cities in the United States. He paid $800 a month for a room, but just slept there.

When traffic was bad, the drive back from work could take as much as three hours. “You would go bumper-to-bumper, bumper-to-bumper sometimes. You get crazy,” Ibarra says.

He considered renting near work. But he couldn’t afford it. He figured he was already spending as much as four hours a day in his vehicle, so he might as well just sleep there.

The plight of low-wage workers like Ibarra is affecting the restaurant business. Just last year, several high-profile eateries shut down. One of them was Camino, known for its wood-fired cuisine. Co-owner Allison Hopelain says the restaurant took a major hit when its chef moved to Seattle because he couldn’t afford to live in the Bay Area.

“[He] felt like he would have better opportunities there in terms of opening his own place, buying a home,” Hopelain says. She says things started unraveling when he left. Last year, after about a decade in business, Camino closed.

Hopelain went on to open The Kebabery in Oakland. It’s a small, cafeteria-style joint. You just pick your food and find a table. She says it’s a much more affordable business model, but she also thinks it’s what a lot of customers want.

Decades ago, eating out was a special occasion, but these days Hopelain says people want to grab a quick, affordable bite of good food and head back to their lives.

Allison Hopelain, owner of The Kebabery in Oakland, Calif., says the cafeteria-style restaurant reflects the changing tastes of customers who now want to grab a quick, affordable meal and head back to their lives. Allison Hopelain/Courtesy of The Kebabery hide caption

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Allison Hopelain/Courtesy of The Kebabery

Allison Hopelain, owner of The Kebabery in Oakland, Calif., says the cafeteria-style restaurant reflects the changing tastes of customers who now want to grab a quick, affordable meal and head back to their lives.

Allison Hopelain/Courtesy of The Kebabery

A few minutes north of Oakland, Peter Levitt says his restaurant, Saul’s, with waiters, hosts and food runners, is part of a dying breed. “Your old diners with booths and breakfast and lunch table service — it’s over,” he says.

Saul’s, a Jewish deli, is a landmark in Berkeley near the University of California campus. Professors and locals hold meetings in the cozy booths over bagels, blintzes, smoked fish and warm matzo ball soup.

Peter Levitt, owner of Saul’s, a Jewish deli in Berkeley, says that as the minimum wage and housing prices climb, “the menu prices have to go up, because you have to pay more to retain your labor force.” Emunah Hauser/Courtesy of Saul’s Restaurant & Delicatessen hide caption

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Emunah Hauser/Courtesy of Saul’s Restaurant & Delicatessen

Peter Levitt, owner of Saul’s, a Jewish deli in Berkeley, says that as the minimum wage and housing prices climb, “the menu prices have to go up, because you have to pay more to retain your labor force.”

Emunah Hauser/Courtesy of Saul’s Restaurant & Delicatessen

Saul’s was established in the 1980s, and Levitt has seen a change in the cost of living here unfold before his eyes. With workers getting pushed out of the Bay Area, he says, “we’ve seen our staff coming from further and further away.” One of his cooks sleeps at his extended family’s house nearby, on workdays, to shorten his commute.

Levitt says Saul’s might have to adapt to the changing times. “As minimum wages go up, and particularly as housing prices go up, the menu prices have to go up, because you have to pay more to retain your labor force,” he says. “And at some point maybe there won’t be enough clientele out there to pay the cost of table service to sustain this kind of restaurant.”

Some restaurants in the area are even turning to automation. Located in San Francisco’s Financial District, Creator offers burgers created by local celebrity chefs.

But the burgers are made by a giant robot that slices the brioche bun, grates the cheese and cuts the tomatoes. The end result: a $6 burger.

The burger-making robot at Creator, an automated restaurant in San Francisco. Aubrie Prick/Courtesy of Creator hide caption

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Aubrie Prick/Courtesy of Creator

The burger-making robot at Creator, an automated restaurant in San Francisco.

Aubrie Prick/Courtesy of Creator

Alex Vardakostas grew up flipping patties at his parents’ restaurant, a burger joint in a little California surf town. He says the robot can flip burgers better, and more cheaply.

“The only way you can make a burger of this kind of quality at that price is using a device that’s going to grind meat to order. It’s going to slice the tomato to order, slice the bun to order,” Vardakostas says.

Meanwhile, at the hotel restaurant where Ibarra works, a burger costs about $20.

“You know, even when I get the discount, that’s too much,” he says.

He says he usually just goes to Burger King or Taco Bell or stops by a gas station to eat before heading back to his van to sleep.

Provided By NPR

Estudio de seguridad revela el riesgo de coágulos de sangre en los pulmones y muerte con una dosis más alta de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide; la FDA investigará

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[2-25-2019] La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de Estados Unidos está alertando al público acerca de un ensayo clínico de seguridad que concluyó que existe un aumento en el riesgo de coágulos de sangre en los pulmones y muerte cuando se utilizó una dosis diaria de 10 mg dos veces al día de tofacitinib (Xeljanz, Xeljanz XR) en pacientes con artritis reumatoide (AR). La FDA no ha aprobado esta dosis diaria de 10 mg dos veces al día para AR; esta dosis sólo está aprobada en la pauta posológica para pacientes con colitis ulcerosa.

En este ensayo clínico de seguridad exigido por la FDA cuando se aprobó tofacitinib para la AR, Pfizer, el fabricante del medicamento, está cambiando a los pacientes que tomaban la dosis diaria más alta de 10 mg dos veces al día a la dosis más baja, que actualmente cuenta con aprobación, de 5 mg diarios dos veces al día. Este ensayo continuará y se espera que finalice para finales de 2019. Estamos trabajando con el fabricante para evaluar otra información de seguridad que está disponible actualmente para tofacitinib y comunicaremos al público cualquier información nueva basándonos en la revisión en curso.

Los profesionales de atención médica deben seguir las recomendaciones en la información de prescripción de tofacitinib para la enfermedad específica que están tratando. Monitoree a los pacientes para detectar indicios y síntomas de embolia pulmonar, y avíseles que deben buscar atención médica de inmediato si presentan cualquiera de ellos.

Los pacientes no deben dejar de tomar o cambiar la dosis de tofacitinib sin primero hablar con su profesional de atención médica, ya que hacerlo puede empeorar su afección. Los pacientes que toman tofacitinib deben buscar atención médica de inmediato si experimentan síntomas de un coágulo de sangre en los pulmones u otros síntomas inusuales como:

  • Falta de aliento o dificultad para respirar repentinos
  • Dolor de pecho o dolor en la espalda
  • Tos con sangre
  • Sudoración excesiva
  • Palidez o color azulado de la piel

Tofacitinib actúa reduciendo la actividad del sistema inmunitario. Se aprobó por primera vez en 2012 para tratar a pacientes adultos con AR que no respondían bien al medicamento metotrexato. En la AR, el cuerpo ataca sus propias articulaciones, ocasionándoles dolor, hinchazón y pérdida de funciones. En 2017, aprobamos el medicamento para tratar pacientes con una segunda afección, la artritis psoriásica, que no tuvieron buena respuesta al metotrexato o a otros medicamentos similares llamados fármacos antirreumáticos modificadores de la enfermedad (FARME) no biológicos. La artritis psoriásica es un trastorno que también ocasiona dolor articular e hinchazón. En 2018, aprobamos tofacitinib para tratar una afección llamada colitis ulcerativa, que es una enfermedad inflamatoria crónica de los intestinos que afecta al colon.

Cuando la FDA aprobó tofacitinib por primera vez, exigimos la realización de un ensayo clínico entre pacientes con AR para evaluar el riesgo de eventos cardíacos, cáncer e infecciones oportunistas con el medicamento en dos dosis (10 mg diarios dos veces al día y 5 mg diarios dos veces al día) en combinación con metotrexato, comparándolo con otro medicamento llamado inhibidor del factor de necrosis tumoral (FNT). Se exigió que los pacientes con AR en el estudio tuvieran al menos 50 años y al menos un factor de riesgo cardiovascular. Durante el análisis más reciente del estudio, un comité de monitoreo de seguridad de datos externo encontró un aumento de la ocurrencia de coágulos de sangre en los pulmones y muerte en pacientes tratados con tofacitinib de 10 mg dos veces al día en comparación con pacientes tratados con tofacitinib de 5 mg dos veces al día o un inhibidor del FNT.

Para ayudar a la FDA a realizar el seguimiento de cuestiones de seguridad con los medicamentos, alentamos a los pacientes y profesionales de atención médica a informar los efectos secundarios que involucren tofacitinib u otros medicamentos al programa MedWatch de la FDA, usando la información del recuadro que aparece al final de la página donde dice “Comuníquese con la FDA”.

https://www.fda.gov/Drugs/DrugSafety/ucm632779.htm

La FDA agrega un Recuadro de advertencia por el aumento en el riesgo de muerte con el medicamento para la gota Uloric (febuxostat)

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[2-21-2019] La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de Estados Unidos ha llegado a la conclusión de que existe un aumento en el riesgo de muerte con Uloric (febuxostat) en comparación con otro medicamento para el tratamiento de la gota llamado allopurinol. Esta conclusión se basa en nuestra revisión profunda de los resultados de un ensayo clínico de seguridad que reveló un aumento en el riesgo de muerte por causas cardíacas y muerte por cualquier causa con Uloric.

Como consecuencia, estamos actualizando la información de prescripción de Uloric para exigir un Recuadro de advertencia, nuestra advertencia más enfática, y una nueva Guía del medicamento para el paciente. También estamos limitando el uso aprobado de Uloric a determinados pacientes cuyo tratamiento no resulta eficaz o que experimentan efectos secundarios graves con allopurinol.

Uloric fue aprobado por la FDA en 2009 para el tratamiento de un tipo de artritis llamada gota en adultos. La gota se produce cuando una sustancia que se genera naturalmente en el cuerpo, denominada ácido úrico, se acumula y causa ataques repentinos de enrojecimiento, hinchazón y dolor en una o más articulaciones. Uloric actúa reduciendo los niveles de ácido úrico en la sangre.

La gota es una enfermedad crónica que afecta a aproximadamente 8.3 millones de adultos en EE. UU.1 La cantidad de medicamentos para tratar la gota es limitada y existe una necesidad insatisfecha de contar con tratamientos para esta enfermedad.

Los pacientes deben decirle al profesional de atención médica si tienen antecedentes de problemas cardíacos o accidente cerebrovascular y discutir los beneficios y riesgos del uso de Uloric para el tratamiento de la gota. Busque atención médica de inmediato si presente los siguientes síntomas mientras toma Uloric:

  • Dolor de pecho
  • Falta de aliento
  • Ritmo cardíaco rápido o irregular
  • Entumecimiento o debilidad en un lado del cuerpo
  • Mareos
  • Dificultad para hablar
  • Dolor de cabeza repentino y severo

No deje de tomar Uloric sin primero consultar con su profesional de atención médica, ya que hacerlo puede empeorar la gota que usted padece.

Los profesionales de atención médica deben reservar el uso de Uloric sólo para pacientes que no responden al allopurinol o que no lo toleran. Aconseje a los pacientes acerca del riesgo cardiovascular con Uloric y avíseles de procurar atención médica inmediata si experimentan los síntomas que se indican más arriba.

Cuando se aprobó Uloric en 2009, incluimos una Advertencia y precaución sobre posibles eventos cardiovasculares para pacientes tratados con Uloric en la información farmacológica actual y exigimos al fabricante del medicamento, Takeda Pharmaceuticals, la realización de un ensayo clínico de seguridad extenso posterior a la comercialización. Se llevó a cabo el ensayo de seguridad en más de 6,000 pacientes con gota tratados o bien con Uloric o bien con allopurinol. El criterio de valoración principal fue una combinación de muerte relacionada con causas cardíacas, ataque cardíaco sin producir la muerte, accidente cerebrovascular sin producir la muerte y la afección de inadecuada irrigación sanguínea al corazón que requiere de una intervención quirúrgica, llamada angina inestable.

Los resultados mostraron que, en general, Uloric no aumentó el riesgo de estos eventos combinados en comparación con allopurinol (consulte el Resumen de datos). Sin embargo, al evaluarse los resultados por separado, Uloric demostró un mayor riesgo de muerte relacionada con causas cardíacas y muerte por cualquier causa.

En pacientes tratados con Uloric, se observaron 15 muertes por causas cardíacas por cada 1,000 pacientes tratados durante un año en comparación con 11 muertes por causas cardíacas por cada 1,000 pacientes tratados con allopurinol durante un año. Además, se produjeron 26 muertes por cualquier causa cada 1,000 pacientes tratados durante un año con Uloric en comparación con 22 muertes cada 1,000 pacientes tratados durante un año con allopurinol. Este ensayo clínico de seguridad también fue analizado en una reunión pública del Comité Asesor de expertos externos el 11 de enero de 2019.

Para ayudar a la FDA a realizar el seguimiento de cuestiones de seguridad con los medicamentos, alentamos a los pacientes y profesionales de atención médica a informar los efectos secundarios que involucren Uloric u otros medicamentos al programa MedWatch de la FDA, usando la información del recuadro que aparece al final de la página donde dice “Comuníquese con la FDA”.

https://www.fda.gov/Drugs/DrugSafety/ucm632408.htm

Oncologic Drugs Advisory Committee Roster

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Applying for Membership on FDA Advisory Committees

As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. More info (Posted 2/27/2007)

Current Number of Vacancies = 0
Note, one or more vacancies may be in the nomination process or a final appointment may have been made.

https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/ucm107418.htm

Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate

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[2-25-2019] The U.S. Food and Drug Administration (FDA) is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.

In this ongoing safety trial required by FDA when it approved tofacitinib for RA, the drug manufacturer, Pfizer, is transitioning patients who were on the high 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily. This trial will continue and is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review.

Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.

Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:

  • Sudden shortness of breath or difficulty breathing
  • Chest pain or pain in your back
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish colored skin

Tofacitinib works by decreasing the activity of the immune system. It was first approved in 2012 to treat adult patients with RA who did not respond well to the medicine methotrexate. In RA, the body attacks its own joints, causing pain, swelling, and loss of function. In 2017, we approved the medicine to treat patients with a second condition, psoriatic arthritis, who did not respond well to methotrexate or other similar medicines called nonbiologic disease-modifying antirheumatic drugs (DMARDs). Psoriatic arthritis is a condition that also causes joint pain and swelling. In 2018, we approved tofacitinib to treat a condition called ulcerative colitis, which is a chronic, inflammatory bowel disease affecting the colon.

When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.

To help FDA track safety issues with medicines, we urge health care professionals and patients to report side effects involving tofacitinib or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

https://www.fda.gov/Drugs/DrugSafety/ucm631871.htm

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

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[Posted 02/25/2019]

AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology

ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

BACKGROUND: When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.

RECOMMENDATION:  Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.

Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:

  • Sudden shortness of breath or difficulty breathing   

  • Chest pain or pain in your back

  • Coughing up blood

  • Excessive sweating

  • Clammy or bluish colored skin

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/25/2019 – Drug Safety Communication – FDA]







https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm

Planned Parenthood President Leana Wen On Trump Administration Title X Changes

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NPR’s Lulu Garcia-Navarro talks with Leana Wen, a physician and the president of Planned Parenthood, about how a rule change from the Trump administration on Title X will affect her organization.

LULU GARCIA-NAVARRO, HOST:

Planned Parenthood, long the target of social conservatives, could lose a significant portion of its funding under a new Trump administration rule released on Friday. The rule will cut federal funding from organizations that make referrals for abortions or provide the procedure. This is a win for anti-abortion activists who pressured lawmakers to defund organizations with ties to abortion.

But critics say it will hurt lower-income women who depend upon family planning centers that receive what are known as Title X funds. Leana Wen is a physician and the president of Planned Parenthood, and she joins us now.

Welcome to WEEKEND EDITION.

LEANA WEN: Thank you, Lulu – good to be with you.

GARCIA-NAVARRO: You call these changes to the Title X program a gag rule. Explain.

WEN: This is a gag rule because what President Trump is doing is to put a gag on doctors like me to prevent us from providing our patients with full and accurate medical information. So if you are a woman who goes to a health center that receives public funding, you cannot be referred to abortion care, even if your life depends on it. This gag rule is unethical and unconscionable.

I mean, imagine if the Trump administration issued a rule that forbid doctors from telling our patients about their options for any other aspect of health care. It’s a direct interference with the practice of medicine and with our ethical obligation to our patients. And this is why over 100 medical and public health organizations oppose the gag rule, including the American Medical Association, the American Nurses Association and the American College of Obstetricians and Gynecologists.

GARCIA-NAVARRO: I’ve read that you won’t accept funds under the new rules.

WEN: Planned Parenthood will never force our doctors and nurses to compromise their ethics. We will never let politicians censor our health care providers and erode the trust that our patients have placed in us, which is to provide them with compassionate, judgment-free and comprehensive care. That’s our promise to our patients.

GARCIA-NAVARRO: But you could receive federal funds if you separated abortion services from family planning centers. The new rules say there needs to be clear physical and financial separation between government-funded services and abortion-related services.

WEN: This Title X gag rule isn’t about providing good medical care. It only does one thing, which is to restrict patients’ access to reproductive health care. It has no basis in medicine or science. And the only effect is going to be preventing 4 million Americans from receiving basic health care, including breast and cervical cancer screenings, affordable birth control and STI tests.

GARCIA-NAVARRO: Religiously affiliated groups are hoping to get the money instead. Conservatives say this provides good alternatives to women.

WEN: We should talk about what is evidence-based, science-based methods for ensuring that all people have access to the health care that they need. Title X is our nation’s program for affordable birth control and health care. And this program is intended to ensure that people with low incomes who live in rural areas or who don’t have health insurance still have access to cancer screenings and preventive care.

And I think it’s important to talk about the individuals who it will affect the most. It will disproportionately affect those who already face the greatest barriers to care. It’s women of color and families of low income. And we need to talk about the discrimination involved here because if you are wealthy and you have private insurance, you can still get the best medical care.

GARCIA-NAVARRO: But religious groups say they could provide those alternatives, that they feel like they too deserve these funds so that there isn’t a monopoly on care.

WEN: Look. I’m a doctor and a scientist. And I need to do what’s best for my patients based on medicine and science. And what we have done for nearly 50 years through Title X is to follow the best available medicine and science. Title X is recognized to be one of the most successful public health programs in reducing sexually transmitted infections and reducing unintended pregnancies. This is what works.

GARCIA-NAVARRO: Leana Wen is the president of Planned Parenthood. Thank you very much.

WEN: Thanks so much, Lulu. And thank you for your time.

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