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  5. Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007
  1. Development Resources

Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007

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 = 76

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
Aripiprazole - Abilify Otsuka Pharmaceutical Company, Ltd Original WR (PDF -251KB)
 
Medical (PDF -2.3MB) Clinical pharmacology (PDF -385KB) Statistical (PDF -251KB)
Balsalazide disodium - Colazal Salix Pharmaceuticals, Inc Original WR (PDF -169KB) Medical (PDF -3.3MB) Clinical pharmacology (PDF -708KB) Statistical (PDF -509KB)
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
Brinzolamide - Azopt  Alcon Research, Ltd. Original WR (PDF -962KB) Medical (PDF -124KB) 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
Carvedilol - Coreg   SmithKline Beecham Corporation d/b/a GlaxoSmithKline Original WR (PDF -307KB)
Amendment (PDF -160KB)
Amendment 2 (PDF -292KB)
Amendment 3 (PDF -200KB)
Amendment 4 (PDF -183KB)
Amendment 5 (PDF -273KB)
Medical (PDF -1.6MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -330KB)
Celecoxib - Celebrex  G.D. Searle L.L.C. Original WR (PDF -176KB)
Amendment (PDF -180KB)
Amendment 2 (PDF -88KB)
Amendment 3 (PDF -627KB)
Amendment 4 (PDF -184KB)
Amendment 5 (PDF -194KB)
Medical (PDF -3.8MB) Clinical pharmacology (PDF -6MB) Statistical (PDF -846KB)
Ciprofloxacin hydrochloride - Cipro Bayer Pharmaceuticals Corporation Original WR (PDF -883KB)
Amendment (PDF -676KB)
Amendment 2 (PDF -740KB)
Medical (PDF -6.8MB) Clinical pharmacology (PDF -1.6MB) Statistical (PDF -2.9MB)
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)
Desflurane USP - Suprane Baxter Healthcare Corporation Original WR (PDF -678KB)
Amendment (PDF -305KB)
Amendment 2 (PDF -65KB)
Medical (PDF -1.2MB) None None
Dorzolamide hydrochloride ophthalmic solution -Trusopt Merck & Co., Inc. Original WR (PDF -265KB)
Amendment (PDF -167KB)
Amendment 2(PDF -120KB)
Medical (PDF -2.9MB) None Statistical (PDF -581KB)
Emtricitabine - Emtriva Gilead Sciences, Inc Original WR (PDF -218KB) Medical (PDF -453KB) Clinical pharmacology (PDF -1.4MB) Statistical (PDF -703KB)
Ertapenem - Invanz   Merck Original WR (PDF -267KB) Medical (PDF -2.9MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -1.4MB)
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 Aventis Pharmaceuticals, Inc. Original WR (PDF -144KB)
Amendment (PDF -270KB)
Medical (PDF -10MB) Clinical pharmacology (PDF -3MB) None
Fludarabine - Fludara Berlex Original WR (PDF -82KB) Medical (PDF -502KB) None None
Fluticasone propionate - Flonase GlaxoSmithKline Original WR (PDF -754KB)
Amendment (PDF -331KB)
Amendment 2 (PDF -133KB)
Medical (PDF -12MB)
DD Summary review (PDF -286KB)
TL Summary review (PDF -1MB)
Clinical pharmacology (PDF -1MB)
Clinical pharmacology (PDF -106KB)
Statistical (PDF 70KB)
Fluticasone propionate - Flovent  GlaxoSmithKline Original WR (PDF -754KB)
Amendment (PDF -331KB)
Amendment 2 (PDF -133KB)
Medical (PDF -12MB)
DD Summary review (PDF -286KB)
TL Summary review (PDF -1MB)
Clinical pharmacology (PDF -1MB)
Clinical pharmacology (PDF -106KB)
Statistical (PDF 70KB)
Fluvastatin sodium - Lescol Novartis Pharmaceuticals Corporation Original WR (PDF -166KB) Medical (PDF - 1.2MB) None Statistical (PDF -866KB)
Fosinopril - Monopril  Bristol-Myers Squibb Original WR (PDF -250KB)
Amendment (PDF -241KB)
Medical (PDF -1.1MB) None Statistical (PDF -282KB)
Gemcitabine hydrochloride - Gemzar Eli Lilly and Company Original WR (PDF -280KB) None None None
Glimepiride - Amaryl Aventis Pharmaceuticals Inc. Original WR (PDF -169KB)
 
Medical (PDF -667KB) None Statistical (PDF -1MB)
Glyburide and metformin HCl - Glucovance Bristol-Myers Squibb Original WR (PDF -213KB)
Amendment (PDF -123KB)
Amendment 2 (PDF -323KB)
Amendment 3 (PDF -185KB)
Amendment 4 (PDF -191KB)
Medical (PDF -1.1MB) None Statistical (PDF -655KB)
Imatinib - Gleevec  Novartis Pharmaceuticals Corporation Original WR (PDF -215KB) Medical (PDF -574KB) Clinical pharmacology (PDF -566KB) Statistical (PDF -574KB)
Imiquimod - Aldara Graceway Pharmaceuticals, LLC Original WR (PDF -162KB)
Amendment (PDF -263KB)
Amendment 2 (PDF -173KB)
Amendment 3 (PDF -240KB)
Amendment 4 (PDF 141KB)
Medical (PDF -2.7MB) Clinical pharmacology (PDF -1.2MB) Statistical (PDF -978KB)
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 - 74 KB)
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
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 - 324 KB)

Medical (PDF - 676 KB)

 

Medical (PDF - 2.5 MB)

Clinical pharmacology (PDF - 378 KB)

Statistical (PDF -223 KB)

 

Statistical (PDF - 345 KB)

Levetiracetam - Keppra UCB Pharma, Inc. Original WR (PDF -14MB)
Amendment (PDF -197MB)
Medical (PDF -3.4MB) Clinical pharmacology (PDF -8.3MB) Statistical (PDF -9.5KB)
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)
Linezolid - Zyvox Pharmacia & Upjohn, Inc. Original WR (PDF -226KB)
Amendment (PDF -638KB)
Amendment 2 (PDF -395KB)
Amendment 3 (PDF -504KB)
Amendment 4 (PDF -470KB)
Medical (PDF -1MB) Clinical pharmacology (PDF -227KB) None
Meloxicam - Mobic Boehringer Ingelheim Pharmaceuticals, Inc. Original WR (PDF -320KB) Medical (PDF -2.2MB) None Statistical (PDF -3MB)
Methylphenidate HCL - Concerta McNeil Consumer & Specialty Pharmaceuticals Original WR (PDF -178KB)
Amendment (PDF -343KB)
Medical (PDF -1.8MB) Clinical pharmacology (PDF -4.5MB) Statistical (PDF -1.1MB)
Metoprolol succinate - Toprol XL AstraZeneca LP Original WR (PDF -193KB) Medical (PDF -2.6MB) Clinical pharmacology (PDF -2.6MB
Addendum (PDF -1MB)
None
Mixed salts of a single-entity amphetamine product - Adderall XR Shire Development, Inc. Original WR (PDF -356KB)
Amendment (PDF -342KB)
Amendment 2 (PDF -308KB)
Medical (PDF -4.9MB) Clinical pharmacology (PDF -11MB) Statistical (PDF -1.1MB)
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
Nelfinavir mesylate - Viracept Agouron Pharmaceuticals Inc.

Original WR (PDF - 346KB)

Amendent (PDF -110KB)

Medical (PDF -6.7MB) Clinical pharmacology (PDF -2.9MB) 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 - 209 KB)
 
Medical (PDF - 912 KB) Clinical pharmacology (PDF - 912 KB) Statistical (PDF - 76 KB)
Ofloxacin ophthalmic solution - Ocuflox  Allergen Inc. Original WR (PDF -141KB)
 
Medical (PDF -648KB)
Medical (PDF -540KB)
None None
Olanzapine - Zyprexa Eli Lilly and Company Original WR (PDF -111KB)
 
Medical (PDF -5.8MB)
Medical (PDF -500KB)
Clinical pharmacology (PDF -1.8MB)
Clinical pharmacology (PDF -551KB)
Statistical (PDF -394KB)
Ondansetron hydrochloride - Zofran GlaxoSmithKline Original WR (PDF -175KB)
Amendment (PDF -303KB))
Amendment 2 (PDF -320KB)
Medical (PDF -5.8MB) Clinical pharmacology (PDF -2.6MB) Statistical (PDF -561KB)
Orlistat - Xenical Hoffmann-La Roche, Inc. Original WR (PDF -329KB) Medical (PDF -1.7MB) Clinical pharmacology (PDF -650KB) Statistical (PDF -670KB)
Oseltamivir phosphate - Tamiflu Hoffmann-La Roche Inc. Original WR (PDF -175KB)
Amendment (PDF -251KB)
Medical (PDF -292KB) None None
Oxaliplatin – Eloxatin Sanofi-Aventis Original WR (PDF -679KB)
Amendment (PDF -283KB)
Medical (PDF -2.5MB) Clinical pharmacology (PDF -4MB) Statistical (PDF -1.2MB)
Oxcarbazepine - Trileptal  Novartis Pharmaceuticals Corporation Original WR (PDF -230KB) Medical (PDF -2.1MB) Clinical pharmacology (PDF -1.5MB) Statistical (PDF -934KB)
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
Rofecoxib - Vioxx Merck & Co., Inc Original WR (PDF -259KB)
Amendment (PDF -182KB)
Amendment 2 (PDF -196KB)
Medical (PDF -6.8MB)
DD (PDF -577KB)
DD2 (PDF -921KB)
CTDL (PDF -765KB)
Clinical pharmacology (PDF -3.5MB )
Clinical pharmacology (PDF -776KB)
Statistical (PDF -2.2MB)
Rosiglitazone - Avandia SB Pharmco Puerto Rico, Inc. (d/b/a GlaxoSmithKline) Original WR (PDF -213KB)
Amendment (PDF -176KB)
Amendment 2 (PDF -323KB
Medical (PDF -3.1MB) None Statistical (PDF -2.5MB)
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)
Sirolimus - Rapamune Wyeth Pharmaceuticals, Inc. Original WR (PDF -234KB) Medical (PDF -2.4KB) Clinical pharmacology (PDF -106KB) Statistical (PDF -422KB)
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)
Temozolomide - Temodar Schering Corporation Original WR (PDF -196KB)
Amendment (PDF -123KB)
Medical (PDF -4.2MB) Clinical pharmacology (PDF -1MB) Statistical (PDF -1.5MB)
Testosterone gel - AndroGel PD Solvay Pharmaceuticals, Inc. on behalf of Unimed Pharmaceuticals, Inc. Original WR (PDF -171KM)
Amendment (PDF -683KB)
Medical (PDF -8.9MB) Clinical pharmacology (PDF -5.7MB)
Clinical pharmacology (PDF -93KB)
Statistical (PDF -817KB)
Timolol Maleate Ophthalmic Gel forming solution – Timolol GFS 0.25% and 0.5% Alcon Research, Ltd. Written Request (PDF - 110KB) Medical (PDF - 775KB) None None
Tolterodine tartrate - Detrol LA   Pfizer Incorporated Original WR (PDF -613KB)
Amendment (PDF -638KB)
Amendment 2 (PDF -148KB)
Amendment 3 (PDF -118KB)
Medical (PDF -601MB)
Medical (PDF -10.6MB)
Clinical pharmacology (PDF -3.3MB) Statistical (PDF -2MB)
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)
Zolpidem tartrate - Ambien Sanofi-aventis, U.S. Inc. Original WR (PDF -186KB) Medical (PDF -3MB) Clinical pharmacology (PDF -436KB) None