Drugs

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)

In accordance with section 504 of FDASIA (Public Law 112-144), the following are the Written Requests issued under 505A(b) or (c) of the Act, and the medical, clinical pharmacology, and statistical reviews of pediatric studies conducted in response to that Written Request. These studies were submitted between January 4, 2002, and September 27, 2007; six months of pediatric exclusivity was granted; and the studies resulted in a label change.

Total Number of Products Studied under BPCA = 43

Drug Sponsor Written Request Medical Review Clinical Pharmacology Review Statistical Review
Alendronate sodium - Fosamax Merck & Co., Inc. Original WR (PDF -410KB)
Amendment (PDF -206KB)
Medical (PDF -1.5MB) Clinical pharmacology (PDF -1.7MB) Statistical (PDF -1003KB)
Anagrelide hydrochloride - Agrylin Shire Pharmaceutical Development Inc. Original WR (PDF -466KB)
Amendment (PDF -447KB) )
Amendment 2 (PDF -310KB)
Medical (PDF -2MB) Clinical pharmacology (PDF -472KB) None
Argatroban - Argatroban Encysive Pharmaceuticals, Inc. Original WR (PDF -169KB)
Amendment (PDF -299KB)
Amendment 2 (PDF -321KB)
Medical (PDF -1.6MB) Clinical pharmacology (PDF -1.1MB) None
Aripiprazole - Abilify Otsuka Pharmaceutical Company, Ltd Original WR (PDF -251KB)
 
Medical (PDF -2.3MB) Clinical pharmacology (PDF -385KB) Statistical (PDF -251KB)
Benazepril hydrochloride - Lotensin Novartis Pharmaceuticals Corporation Original WR (PDF -363KB)
Amendment (PDF -416KB)
Medical (PDF -1MB) Clinical pharmacology (PDF -1.9MB) Statistical (PDF -590KB)
Betaxolol hydrochloride ophthalmic suspension - Betoptic S Alcon Laboratories, Inc. Original WR (PDF -276KB) Medical (PDF -1.7MB)
Medical (PDF -83KB)
None None
Budesonide inhalation suspension - Pulmicort Respules AstraZeneca Pharmaceuticals Original WR (PDF -352KB)
Amendment (PDF -153KB)
Amendment 2 (PDF -120KB)
Amendment 3 (PDF -139KB)
Amendment 4 (PDF -62KB)
Amendment 5 (PDF -132KB)
Medical (PDF -1.8MB) None None
Citalopram - Celexa Forest Labs Original WR (PDF -414KB)
 
Medical (PDF -305KB)
 
Clinical pharmacology (PDF -7.5MB) None
Clofarabine - Clolar Genzyme Corporation Original WR (PDF -162KB)
Amendment (PDF -301KB)
Medical (PDF -1.7MB) Clinical pharmacology (PDF -165KB) Statistical (PDF -1.7MB)
Emtricitabine - Emtriva Gilead Sciences, Inc Original WR (PDF -218KB) Medical (PDF -453KB) Clinical pharmacology (PDF -1.4MB) Statistical (PDF -703KB)
Fenoldopam mesylate - Corlopam Abbott Laboratories None Medical (PDF -2.2MB) Clinical pharmacology (PDF -3.5MB) None
Fentanyl Transdermal System - Duragesic Alza Corporation Original WR (PDF -189KB)
Amendment (PDF -105KB)
Amendment 1 (PDF -192KB)
Medical (PDF -3MB) Clinical pharmacology (PDF -997KB) None
Fexofenadine HCL - Allegra New! Aventis Pharmaceuticals, Inc. Original WR (PDF -144KB)
Amendment (PDF -270KB)
Medical (PDF -10MB) Clinical pharmacology (PDF -3MB) None
Fluvastatin sodium - Lescol Novartis Pharmaceuticals Corporation Original WR (PDF -166KB) Medical (PDF - 1.2MB) None Statistical (PDF -866KB)
Fludarabine - Fludara Berlex Original WR (PDF -82KB) Medical (PDF -502KB) None None
Glimepiride - Amaryl Aventis Pharmaceuticals Inc. Original WR (PDF -169KB)
 
Medical (PDF -667KB) None Statistical (PDF -1MB)
Insulin aspart - NovoLog Novo Nordisk Inc. Original WR (PDF -349KB)
Amendment (PDF -145KB)
Amendment 2 (PDF -198KB)
Amendment 3 (PDF -295KB)
Amendment 6 (PDF -316KB)
Medical (PDF -898KB) None Statistical (PDF -526KB)
Irbesartan - Avapro Bristol-Myers Squibb Original WR (PDF -551KB) Medical (PDF -1.2MB) Clinical pharmacology (PDF -6.7MB) Statistical (PDF -441KB)
Irinotecan hydrochloride - Campostar Pfizer Inc Original WR (PDF -276KB) Medical (PDF -4.6MB) Clinical pharmacology (PDF -4.5MB) None
Gemcitabine hydrochloride - Gemzar Eli Lilly and Company Original WR (PDF -280KB) None None None
Lamotrigine - Lamictal SmithKlineBeecham Original WR (PDF -319KB) Medical (PDF -5.6MB) Clinical pharmacology (PDF -4MB) None
Lansoprazole - Prevacid TAP Pharmaceutical Products Inc. Original WR (PDF 316KB)
Amendment (PDF -246KB)
Amendment 2 (PDF -125KB)
Amendment 3 (PDF -163KB
Amendment 6 (PDF -604KB)
Medical (PDF -3.5MB) Clinical pharmacology (PDF -432KB) Statistical (PDF -580KB)
Leflunomide - Arava Aventis Pharmaceuticals Inc. Original WR (PDF -324KB) None Clinical pharmacology (PDF - 236KB) None
Levobetaxolol hydrochloride ophthalmic suspension - Betaxon Alcon Research, Ltd. Original WR (PDF -962KB) Medical (PDF -124KB) None None
Levofloxacin - Levaquin Ortho-McNeil Pharmaceutical, Inc.c/o Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Original WR (PDF -141KB)
Amendment (PDF -158KB)
Amendment 2 (PDF -188KB)
Medical (PDF -1MB) Clinical pharmacology (PDF -174KB)
Clinical pharmacology 2 (PDF -1.7MB)
Clinical pharmacology review (PDF -178KB)
Statistical (PDF -71KB)
Metoprolol succinate - Toprol XL AstraZeneca LP Original WR (PDF -193KB) Medical (PDF -2.6MB) Clinical pharmacology (PDF -2.6MB
Addendum (PDF -1MB)
None
Modafinil - Provigil Cephalon, Inc. Original WR (PDF -294KB)
 
Medical (PDF -3.8MB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF -179KB)
Nefazodone hydrochloride - Serzone Bristol-Myers Squibb Company Original WR (PDF -443KB)
 
Medical (PDF -1.3MB) Clinical pharmacology (PDF -1MB) None
Norgestimate/Ethinyl estradiol - Ortho Tri-Cyclen Ortho-McNeil Pharmaceutical, Inc. Original WR (PDF -170KB)
Amendment (PDF -182KB)
Amendment 2 (PDF -309KB)
Medical (PDF -260MB) Clinical pharmacology (PDF -1.4MB) Statistical (PDF -1.4MB)

Octreotide acetate - Sandostatin Lar Depot Injection

 

Novartis Pharmaceuticals Corporation Original WR (PDF -230KB)
 
Medical (PDF -2.2MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -1.2MB)
Oseltamivir phosphate - Tamiflu Hoffmann-La Roche Inc. Original WR (PDF -175KB)
Amendment (PDF -251KB)
Medical (PDF -292KB) None None
Oxybutynin chloride - Ditropan XL Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Original WR (PDF -200KB) Medical (PDF -2.9MB) Clinical pharmacology (PDF -380KB) None
Paricalcitol - Zemplar Abbott Laboratories Original WR (PDF -188KB)
Amendment (PDF -151KB)
Medical (PDF -538KB) None Statistical (PDF -914KB)
Paroxetine hydrochloride - Paxil GlaxoSmithKline Original WR (PDF -495KB)
Amendment (PDF -236KB)
Medical (PDF -3.2MB) Clinical pharmacology (PDF -1MB) None
Risperidone - Risperdal Johnson & Johnson PR&D Original WR (PDF -340KB) Medical (PDF -2.5MB) Clinical pharmacology (PDF -2MB)
Clinical pharmacology (PDF - 141KB)
Statistical (PDF -441KB)
Ritonavir - Norvir Abbott Laboratories Original WR (PDF -162KM)
Amendment (PDF -238KB)
Medical (PDF -256KB) Clinical pharmacology (PDF -752KB) None
Salmeterol xinafoate - Serevent GlaxoSmithKline Original WR (PDF -258KB)
 
Medical (PDF -10.6MB) None Statistical (PDF -68KB)
Sertraline hydrochloride - Zoloft Pfizer Inc. Original WR (PDF -285KB)
Amendment (PDF -196KB)
Medical (PDF -2MB) None Statistical (PDF -230KB)
Sibutramine hydrochloride monohydrate - Meridia Abbott Laboratories Original WR (PDF -292KB Medical (PDF -2.6MB) Clinical pharmacology (PDF -6MB)
Clinical pharmacology (PDF - 135KB)
Statistical (PDF -971KB)
Statistical (PDF - 207KB)
Sodium ferric gluconate complex in sucrose - Ferrlecit Watson Pharma, Inc. Original WR (PDF -188KB) Medical (PDF -1.2MB) Clinical pharmacology (PDF -1.1MB) Statistical (PDF -174KB)
Sumatriptan - Imitrex GlaxoSmithKline Original WR (PDF -271KB)
Amendment (PDF -134KB)
Amendment 2 (PDF -119KB)
Medical (PDF -2MB) Clinical pharmacology (PDF -445KB) Statistical (PDF -378KB)
Venlafaxine - Effexor XR Wyeth Pharmaceuticals, Inc. Original WR (PDF -396KB)
Amendment (PDF -158KB)
Medical (PDF -2MB) Clinical pharmacology (PDF -3MB) Statistical (PDF -172KB)
Zolmitriptan - Zomig AstraZeneca Pharmaceuticals LP Original WR (PDF -324KB)
Amendment (PDF -127KB)
Medical (PDF -5.8MB)
Medical (PDF -1.8MB)
Clinical pharmacology (PDF -903KB) Statistical (PDF -393KB)

 

Page Last Updated: 09/05/2014
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