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Drugs
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Pediatric Exclusivity Granted
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 = 186
Total Approved Active Moieties Granted Exclusivity = 163
Total Approved Drugs Granted Exclusivity = 172
| Drugs Granted Exclusivity | Sponsor |
|---|---|
| Abacavir | Glaxo Wellcome, Inc. |
| Albuterol | GlaxoSmithKline |
| Alendronate | Merck |
| Almotriptan | Johnson & Johnson |
| 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 |
| Bicalutamide | AstraZeneca |
| Bisoprolol | Wyeth Ayerst |
| Bivalirudin | The Medicines Company |
| Brimonidine | Allergan |
| Brinzolamide | Alcon |
| Budesonide | AstraZeneca |
| Buspirone | Bristol-Myers Squibb |
| Busulfan | Orphan Medical |
| Calcitriol | Abbott Laboratories |
| Candesartan | AstraZeneca |
| Caspofungin | Merck |
| Carboplatin | Bristol-Myers Squibb |
| Carvedilol | GlaxoSmithKline |
| Celecoxib | G.D. Searle |
| Cetirizine | Pfizer |
| Ciprofloxacin | Alcon |
| Ciprofloxacin | Bayer |
| Citalopram | Forest |
| Clofarabine | Genzyme |
| Colesevelam | Daiichi Sankyo Pharma |
| Cromolyn | Pharmacia and Upjohn |
| Desflurane | Baxter |
| Desloratadine | Schering |
| Didanosine | Bristol-Myers Squibb |
| Dorzolamide | Merck |
| Emtricitabine | Gilead |
| Enalapril | Merck |
| Eplerenone | Pfizer |
| Ertapenem | Merck |
| Esmolol | Baxter |
| Esomeprazole* | AstraZeneca |
| Etodolac | Wyeth Ayerst |
| Ezetimibe | Schering |
| Famciclovir | Novartis |
| 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 |
| Gatifloxacin | Allergan |
| 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 |
| Levocetirizine | UCB |
| 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 |
Olmesartan  |
Daiichi Sankyo |
| Olopatadine | Alcon |
| Omeprazole | AstraZeneca |
| Ondansetron | GlaxoSmithKline |
| Orlistat | Hoffmann-La Roche |
| Oseltamivir | Hoffmann-La Roche |
| Oxaliplatin | Sanofi-Aventis |
| Oxaprozin | Searle |
| Oxcarbazepine | Novartis |
| Oxybutynin | Alza |
| Pantoprazole | Wyeth Pharmaceuticals, Inc. |
| Paricalcitol | Abbott |
| Paroxetine | GlaxoSmithKline |
| Pemirolast | Santen |
| Pimecrolimus | Novartis |
| Pravastatin | Bristol-Myers Squibb |
| Propofol | Zeneca Pharmaceuticals |
| Quetiapine | AstraZeneca |
| Quinapril | Parke-Davis |
| Ranitidine | Glaxo Wellcome, Inc. |
| Remifentanil | Abbott Laboratories |
| Ribavirin/Intron A | Schering Corporation |
| Risedronate | Procter & Gamble |
| Risperidone | Janssen |
| Ritonavir | Abbott |
| Rocuronium | Organon |
| Rofecoxib | Merck |
| Rosiglitazone | GlaxoSmithKline |
| Rosuvastatin | AstraZeneca |
| 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 |
| Tamsulosin | Boehringer Ingelheim |
| 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
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