Approved Active Moieties to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act

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FDA/Center for Drug Evaluation and Research

Drugs to Which FDA has Granted Pediatric Exclusivity for Pediatric Studies under Section 505A of
the Federal Food, Drug, and Cosmetic Act

NOTE: This list simply identifies approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies. Only applications held by the identified sponsor were granted pediatric exclusivity. This page is updated each time a drug has been granted pediatric exclusivity.

Total Exclusivity Determinations = 170

Total Approved Active Moieties Granted Exclusivity = 149

Total Approved Drugs Granted Exclusivity = 155

Drugs Granted Exclusivity	Sponsor
Abacavir	Glaxo Wellcome, Inc.
Alendronate	Merck
Amlodipine	Pfizer
Ammonium lactate	Westwood-Squibb
Amphetamines mixed	Shire
Anagrelide	Shire
Anastrozole	AstraZeneca
Aripiprazole	Otsuka
Atomoxetine	Lilly
Atorvastatin	Pfizer
Atovaquone/Proguanil	GlaxoSmithKline
Azelastine	Asta Medica
Balsalazide	Salix
Benazepril	Novartis
Betaxolol	Alcon
Bisoprolol	Wyeth Ayerst
Brimonidine	Allergan
Brinzolamide	Alcon
Budesonide	AstraZeneca
Buspirone	Bristol-Myers Squibb
Busulfan	Orphan Medical
Calcitriol	Abbott Laboratories
Caspofungin	Merck
Carboplatin	Bristol-Myers Squibb
Carvedilol	GlaxoSmithKline
Celecoxib	G.D. Searle
Cetirizine	Pfizer
Ciprofloxacin	Alcon
Ciprofloxacin	Bayer
Citalopram	Forest
Clofarabine	Genzyme
Desflurane	Baxter
Cromolyn	Pharmacia and Upjohn
Desloratadine	Schering
Didanosine	Bristol-Myers Squibb
Dorzolamide	Merck
Emtricitabine	Gilead
Enalapril	Merck
Eplerenone	Pfizer
Ertapenem	Merck
Esmolol	Baxter
Etodolac	Wyeth Ayerst
Ezetimibe	Schering
Famotidine	Merck
Felodipine	AstraZeneca
Fentanyl	Alza
Fexofenadine	Aventis
Fludarabine	Berlex
Fluoxetine	Lilly
Fluticasone	GlaxoSmithKline
Fluconazole	Pfizer
Fluvastatin	Novartis
Fluvoxamine	Solvay Pharmaceuticals
Fosinopril	Bristol-Myers Squibb
Gabapentin	Parke-Davis
Gemcitabine	Lilly
Glimepiride	Aventis
Glyburide/Metformin^¨	Bristol-Myers Squibb
Ibuprofen	McNeil Consumer Products Co.
Ibuprofen	Whitehall-Robbins Healthcare
Ibuprofen^¨/pseudoephedrine	Whitehall-Robbins Healthcare
Imatinib	Novartis
Imiquimod	3M
Insulin Aspart	Novo Nordisk
Insulin glargine	Aventis
Irbesartan	Sanofi-Synthelabo
Irinotecan	Pfizer
Isotretinoin	Hoffmann-La Roche, Inc.
Ketorolac	Allergan
Lamivudine	Glaxo Wellcome, Inc
Lamivudine ^¨	Glaxo Wellcome, Inc
Lamotrigine	GlaxoSmithKline
Lansoprazole	Tap Pharmaceutical Products, Inc.
Leflunomide	Aventis
Levetiracetam	UCB Inc.
Levobetaxolol	Alcon
Levofloxacin	Ortho McNeil
Lisinopril	AstraZeneca
Linezolid	Pfizer
Lisinopril	Merck
Lopinavir / Ritonavir ^¨	Abbott
Loratadine	Schering Corporation
Losartan	Merck
Lovastatin	Merck
Meloxicam	Boehringer Ingelheim
Metformin	Bristol-Myers Squibb
Methylphenidate	McNeil
Metoprolol	AstraZeneca
Midazolam	Hoffmann-La Roche, Inc.
Milrinone	Sanofi-Synthelabo
Modafinil	Cephalon
Mometasone	Schering Corporation
Montelukast	Merck
Moxifloxacin	Alcon
Nabumetone	SmithKline
Nefazodone	Bristol-Myers Squibb
Nelfinavir	Agouron
Nevirapine	Boehringer Ingelheim
Norgestimate/ethinyl estradiol	Johnson & Johnson
Octreotide	Aventis
Ofloxacin	Allergan
Olanzapine	Lilly
Omeprazole	AstraZeneca
Ondansetron	GlaxoSmithKline
Orlistat	Hoffmann-La Roche
Oseltamivir	Hoffmann-La Roche
Oxaliplatin	Sanofi-Aventis
Oxaprozin	Searle
Oxcarbazepine	Novartis
Oxybutynin	Alza
Paricalcitol	Abbott
Paroxetine	GlaxoSmithKline
Pemirolast	Santen
Pimecrolimus	Novartis
Pravastatin	Bristol-Myers Squibb
Propofol	Zeneca Pharmaceuticals
Quinapril	Parke-Davis
Ranitidine	Glaxo Wellcome, Inc.
Remifentanil	Abbott Laboratories
Ribavirin/Intron A	Schering Corporation
Risperidone	Janssen
Ritonavir	Abbott
Rocuronium	Organon
Rofecoxib	Merck
Rosiglitazone	GlaxoSmithKline
Salmeterol	GlaxoSmithKline
Sertraline	Pfizer
Sevoflurane	Abbott Laboratories
Sibutramine	Abbott Laboratories
Simvastatin	Merck
Sirolimus	Wyeth
Sodium ferric gluconate complex	Watson Pharmaceuticals
Sotalol	Berlex Laboratories
Stavudine	Bristol-Myers Squibb
Sumatriptan	GlaxoSmithKline
Tamoxifen	AstraZeneca
Technetium Tc99 sestamibi	BMS
Temozolomide	Schering
Terbinafine	Novartis
Testosterone	Unimed Pharmaceuticals
Timolol	Falcon
Tipranavir	Boehringer Ingelheim
Tolterodine	Pfizer
Topiramate	Ortho-McNeil-Janssen Pharm, Inc.
Topotecan	GlaxoSmithKline
Tramadol	R.W. Johnson
Valacyclovir	GlaxoSmithKline
Valganciclovir	Hoffman-La Roche, Inc.
Valproate	Abbott
Valsartan	Novartis
Venlafaxine	Wyeth-Ayerst
Vinorelbine	GlaxoSmithKline
Zoledronic acid	Novartis
Zolmitriptan	AstraZeneca
Zolpidem	Sanofi-Aventis

¨ Active Moieties Granted Second Period of Pediatric Exclusivity

Date created: June 10, 2005; Last updated: August 7, 2008