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

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

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 = 159 Updated 2/15/2008

Total Approved Active Moieties Granted Exclusivity = 140 Updated 2/15/2008

Total Approved Drugs Granted Exclusivity = 145 Updated 2/15/2008

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
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
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
Leflunomide Aventis
Levobetaxolol Alcon
Levofloxacin Ortho McNeil
Lisinopril AstraZeneca
Linezolid Pfizer
Lisinopril Merck
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
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 New!! BMS
Temozolomide Schering
Terbinafine Novartis
Testosterone Unimed Pharmaceuticals
Timolol Falcon
Tolterodine Pfizer
Topotecan GlaxoSmithKline
Tramadol R.W. Johnson
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


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