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Drugs
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Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B(h)(1) of the Act (Pediatric Research Equity Act of 2007 (PREA)), as amended by FDAAA (Pub. L. No. 110-85), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Total Number of Products Studied under BPCA = 31
Total Number of Products Studied under PREA = 42
| Drug | Sponsor | Reviews | BPCA or PREA | ||
|---|---|---|---|---|---|
| Abacavir - Ziagen | GlaxoSmithKline | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Abatacept - Orencia | Novartis Pharmaceuticals Corp. | Medical [PDF][*note for vision impaired users] | Clinical pharmacology [PDF][*note for vision impaired users] | Statistical [PDF][*note for vision impaired users] | PREA |
| Adalimumab - Humira | Abbot | Medical [PDF][*note for vision impaired users] | Clinical pharmacology [PDF][*note for vision impaired users] | Statistical [PDF][*note for vision impaired users] | PREA |
| Adapalene - Epiduo | Galderma Laboratories LP | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Adefovir - Hepsera | Gilead Sciences Inc | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Albuterol sulfate HFA - Ventolin HFA | GlaxoSmithKline | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Almotriptan - Axert | Johnson and Johnson | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Amoxicillin/APC -111 - Moxatag | MiddleBrook Pharmaceuticals | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Anastrozole - Arimidex | AstraZeneca | Medical [PDF] | Clinical pharmacology [PDF][*note for vision impaired users] | Statistical [PDF] | BPCA |
| Argatroban - Argatroban | ENCYSIVE Pharmaceuticals Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Aripiprazole - Abilify | Otsuka Pharmaceutical Company | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Azelastine hydrochloride - Astepro | MEDA |
Medical [PDF] Medical [PDF] |
Clinical pharmacology [PDF] |
Statistical [PDF] Statistical [PDF] |
PREA |
| Azithromycin - Zmax | Pfizer | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Benzyl Alcohol - Ulesfia Asphyxiator | Sciele® Pharma, Inc | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Bepotastine besilate - Bepreve | Ista Pharmaceuticals, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Besifloxacin hydrochloride - Besivance | Bausch & Lomb | Medical [PDF][*note for vision impaired users] | Clinical pharmacology [PDF] | Statistical [PDF][*note for vision impaired users] | PREA |
| Bicalutamide - Casodex | AstraZeneca Pharmaceuticals | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Brimonidine tartrate - Timolol maleate - Combigan | Allergen, Inc. | Medical [PDF][*note for vision impaired users] | Clinical pharmacology [PDF][*note for vision impaired users] | Statistical [PDF][*note for vision impaired users] | PREA |
Candesartan Cilexitil - Atacand  |
Astra Zeneca | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Caspofungin acetate - Cancidas | Merck | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Ciclesonide - Alvesco | Aventis | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Ciclesonide - Omnaris | NYCOMED | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Ciprofloxacin otic solution - Cetraxal | Parexel International | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Clindamycin Phosphate/Benzoyl Peroxide -Acanya Gel | Dow Pharmaceutical Sciences, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Colesevelam hydrochloride - Welcho | Daiichi-Sankyo | Medical [PDF] | None | Statistical [PDF] | BPCA |
| Darunavir - Prezista | Tibotec | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Desmopressin acetate - Minirin | Ferring Pharmaceuticals Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Dexmethylphenidate hydrochloride - Focalin XR | Novartis Pharmaceuticals | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Didanosine - Videx EC | Bristol-Myers Squibb Company | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Divalproex - Depakote ER | Abbott |
Medical [PDF] Medical [PDF] Medical [PDF] |
Clinical pharmacology [PDF] | None | BPCA |
| Divalproex - Depakote Sprinkle | Abbott | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Eplerenone - Inspra | GD Searle LLC | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Esomeprazole magnesium - Nexium | AstraZeneca | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Esomeprazole magnesium - Nexium | AstraZeneca | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Ezetimbe/simvastatin - Vytorin | Merck Schering-Plough Singapore Co., LLC | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Ezetimbe - Zetia | Merck Schering Plough Singapore Co., LLC |
Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Fluocinolone acetonide - Derma-Smoothe/FS | Hill Dermaceuticals, Inc | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Gatifloxacin - Zymar | Allergan, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Helioblock SX - Anthelios 40 | L’Oreal USA | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Insulin Aspart - NovoLog | Novo Nordisk, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Insulin glulisine - Apidra | Sanofi-Aventis | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Lamotrigine - Lamictal XR | GlaxoSmithKline | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Lansoprazole Oral Suspension - Prevacid | TAP Pharmaceutical Products | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Levetiracetam - Keppra | UCB, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Levocetirizine dihydrochloride - Xyzal | UCB Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Levocetirizine dihydrochloride - Xyzal | UCB Inc | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Lidocaine hydrochloride - Akten | Akorn, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Lopinavir/ritonavir - Kaletra | Abbott | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Mometasone furoate - Asmanex Twisthaler | Schering Plough Corporation | Medical [PDF] | Clinical pharmacology [PDF] | Statistical Statistical [PDF] | PREA |
| Nevirapine - Viramune | Boehringer Ingelheim | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Olopatadine hydrochloride - Patanase | Alcon Research, Ltd. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Omeprazole magnesium - Prilosec | AstraZeneca LLP | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Pancrelipase - Zentase | Eurand Pharmaceuticals Ltd. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Peginterferon - PegIntron | Schering-Plough Research Institute | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Peginterferon - PegIntron | Amgen | Medical [PDF] [*note for vision impaired users] | Clinical pharmacology [PDF] [*note for vision impaired users] | None | PREA |
| Phentolamine - OraVerse | Novalar Pharmaceuticals, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Rabeprazole sodium - Aciphex |
Eisai Medical Research Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Risedronate sodium - Actonel | Procter & Gamble Pharmaceuticals, Inc | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Rocuronium bromide - Zemuron | Organon USA, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Somatropin - Accretropin | Cangene Corporation | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Sterile Intraocular - Navstel Intraocular Irrigating Solution | Alcon, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Technetium Tc99m - Sestamibi | Bristol Myers Squibb | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Terbinafine - Lamisil | Novartis Pharmaceuticals Corp. | Medical [PDF][*note for vision impaired users] | Clinical pharmacology [PDF][*note for vision impaired users] | Statistical [PDF][*note for vision impaired users] | BPCA |
| Tipranavir - Aptivus | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Topiramate - Topamax | Johnson and Johnson Pharmaceutical Research & Development L.L.C. |
Medical [PDF] | Clinical pharmacology [PDF] | None | BPCA |
| Triamcinolone acetonide - Triesence | Alcon, Inc. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Triamcinolone acetonide - Nasacort AQ | Sanofi Aventis | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
| Valacyclovir hydrochloride - Valtrex | GlaxoSmithKline | Medical [PDF] |
Clinical pharmacology [PDF] Clinical pharmacology [PDF] |
None | BPCA |
| Valsartan - Diovan | Novartis | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Zidovudine, ZDV - Retrovir | GlaxoSmithKline | Medical [PDF] | Clinical pharmacology [PDF] | None | PREA |
| Zoledronic acid - Zometa | Novartis Pharmaceutical Corp. | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | BPCA |
| Zolmitriptan - Zomig | AstraZeneca | Medical [PDF] | Clinical pharmacology [PDF] | Statistical [PDF] | PREA |
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