Approved Active Moieties 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 moieties with sponsors to which FDA has granted exclusivity for pediatric studies. Only applications held by the identified sponsor were granted pediatric exclusivity.
Total Exclusivity Determinations = 113
Total Approved Active Moieties Granted Exclusivity = 97
Total Approved Drugs Granted Exclusivity = 103
|
Active Moiety |
Sponsor |
|
Abacavir |
Glaxo Wellcome, Inc. |
| Alendronate | Merck |
|
Amlodipine |
Pfizer |
|
Ammonium lactate |
Westwood-Squibb |
| Amphetamines mixed | Shire |
| Anagrelide | Shire |
| Atomoxetine | Lilly |
|
Atorvastatin |
Pfizer |
| Atovaquone/Proguanil | GlaxoSmithKline |
|
Azelastine |
Asta Medica |
| Benazepril | Novartis |
|
Bisoprolol |
Wyeth Ayerst |
|
Brimonidine |
Allergan |
| Budesonide | AstraZeneca |
|
Buspirone |
Bristol-Myers Squibb |
|
Busulfan |
Orphan Medical |
|
Calcitriol |
Abbott Laboratories |
|
Carboplatin |
Bristol-Myers Squibb |
|
Cetirizine |
Pfizer |
| Ciprofloxacin | Alcon |
| Ciprofloxacin | Bayer |
| Citalopram | Forest |
| Clofarabine | Ilex |
|
Cromolyn |
Pharmacia and Upjohn |
| Desloratadine | Schering |
|
Didanosine |
Bristol-Myers Squibb |
| Dorzolamide | Merck |
|
Enalapril |
Merck |
| Esmolol | Baxter |
|
Etodolac |
Wyeth Ayerst |
|
Famotidine |
Merck |
|
Felodipine |
Astra Zeneca |
| Fentanyl | Alza |
| Fexofenadine | Aventis |
| Fludarabine | Berlex |
|
Fluoxetine |
Lilly |
| Fluticasone | GlaxoSmithKline |
| Fluconazole | Pfizer |
|
Fluvoxamine |
Solvay Pharmaceuticals |
| Fosinopril | Bristol-Myers Squibb |
|
Gabapentin |
Parke-Davis |
| Glyburide/Metformin¨ | Bristol-Myers Squibb |
|
Ibuprofen |
McNeil Consumer Products Co. |
|
Ibuprofen |
Whitehall-Robbins Healthcare |
| Ibuprofen¨/pseudoephedrine | Whitehall-Robbins Healthcare |
|
Insulin glargine |
Aventis |
| Irbesartan | Sanofi-Synthelabo |
| Irinotecan | Pfizer |
|
Isotretinoin |
Hoffmann-La Roche, Inc. |
|
Ketorolac |
Allergan |
| Lamivudine | Glaxo Wellcome, Inc |
|
Lamivudine ¨ |
Glaxo Wellcome, Inc |
| Leflunomide | Aventis |
|
Lisinopril |
Astra Zeneca |
|
Lisinopril |
Merck |
|
Loratadine |
Schering Corporation |
|
Losartan |
Merck |
|
Lovastatin |
Merck |
|
Metformin |
Bristol-Myers Squibb |
| Methylphenidate | McNeil |
|
Midazolam |
Hoffmann-La Roche, Inc. |
|
Milrinone |
Sanofi-Synthelabo |
|
Mometasone |
Schering Corporation |
|
Montelukast |
Merck |
| Moxifloxacin | Alcon |
|
Nabumetone |
SmithKline |
| Nefazodone | Bristol-Myers Squibb |
| Nelfinavir | Agouron |
|
Nevirapine |
Boehringer Ingelheim |
| norgestimate/ethinyl estradiol | Johnson & Johnson |
| Ofloxacin | Allergan |
|
Omeprazole |
Astra Zeneca |
| Orlistat | Hoffmann-La Roche |
| Oseltamivir | Hoffmann-La Roche |
|
Oxaprozin |
Searle |
|
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 |
| Rofecoxib | Merck |
|
Sertraline |
Pfizer |
|
Sevoflurane |
Abbott Laboratories |
| Sibutramine | Abbott Laboratories |
|
Simvastatin |
Merck |
| Sodium ferric gluconate complex | Watson Pharmaceuticals |
|
Sotalol |
Berlex Laboratories |
|
Stavudine |
Bristol-Myers Squibb |
| Sumatriptan | GlaxoSmithKline |
|
Tamoxifen |
AstraZeneca |
| Temozolomide | Schering |
| Tolterodine | Pfizer |
| Topotecan | GlaxoSmithKline |
|
Tramadol |
R.W. Johnson |
| Venlafaxine | Wyeth-Ayerst |
| Vinorelbine | GlaxoSmithKline |
| Zolmitriptan | AstraZeneca |
¨ Active Moieties Granted Second Period of Pediatric Exclusivity
Last Updated: October 29, 2004
(http://www.fda.gov/cder/pediatric/exgrant.htm)