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.
Find the Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007 in the FDA Archive
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 |