Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies as of June 1998. If a product appears on this list, it does not imply that studies have been conducted or submitted to the Agency, nor does it mean that the studies described in the Written Request will be conducted. A sponsor is NOT required to perform pediatric studies in response to a Written Request. Conducting pediatric studies in response to a Written Request is voluntary. Upon occasion, information obtained by FDA subsequent to issuance of a Written Request causes FDA to rescind the Written Request. This list is not updated to indicate when a Written Request has been rescinded.
Total Approved Active Moieties Issued a Written Request = 253
| Active Moiety | Sponsor |
|---|---|
|
Abacavir |
Glaxo Wellcome, Inc. |
|
Acetazolamide |
Wyeth-Ayerst |
| Adefovir | Gilead |
|
Albuterol |
Dey |
| Albuterol | GlaxoSmithKline |
|
Alendronate |
Merck |
|
Almotriptan |
Pharmacia & Upjohn |
|
Alosetron |
Glaxo Wellcome, Inc. |
| Alprazolam | Pharmacia & Upjohn |
|
Amiodarone |
Wyeth Ayerst |
|
Amlexanox |
Block Drug |
|
Amlodipine |
Pfizer, Inc. |
|
Amlodipine/Benazepril |
Novartis |
|
Ammonium Lactate |
Westwood Squibb |
| Amphetamine (mixed salts) | Shire |
|
Amprenavir |
Glaxo Wellcome, Inc. |
| Anagrelide | Shire |
|
Anastrozole |
Astra Zeneca |
| Argatroban | Texas Biotechnology |
| Aripiprazole | Otsuka |
| Atazanavir | Bristol-Myers Squib |
| Atomoxetine | Lilly |
|
Atorvastatin |
Warner-Lambert |
|
Atovaquone/Proguanil |
Glaxo Wellcome, Inc. |
|
Azelastine |
ASTA Medica |
| Baclofen | Schwarz |
|
Balsalazide |
Salix Pharm. |
|
Beclomethasone |
Schering |
| Beclomethasone | 3M |
|
Benazepril |
Novartis |
|
Betamethasone |
Schering |
|
Betaxolol |
Lorex Pharmaceuticals |
|
Betaxolol |
Alcon |
| Bicalutamide | AstraZenenca Pharm. |
|
Bisoprolol |
Wyeth-Ayerst |
|
Brimonidine |
Allergan, Inc. |
|
Brinzolamide |
Alcon |
|
Budesonide |
Astra Zeneca |
|
Buproprion |
Glaxo Wellcome, Inc |
|
Buspirone |
Bristol-Myers Squibb |
|
Busulfan |
Orphan Medical |
| C-Urea | Meretek |
|
Calcitriol |
Abbott |
|
Candesartan |
Astra Pharmaceuticals |
|
Carboplatin |
Bristol-Myers Squibb |
|
Carteolol |
CIBA |
|
Carvedilol |
SmithKline Beecham |
|
Caspofungin |
Merck |
|
Celecoxib |
Searle |
|
Cerivastatin |
Bayer |
|
Cetirizine |
Pfizer |
|
Cilostazol |
Otsuka |
|
Cimetidine |
SmithKline Beecham |
|
Ciprofloxacin |
Bayer |
|
Ciprofloxacin |
Alcon |
|
Cisatracurium |
Glaxo Wellcome |
|
Citalopram |
Forest Laboratories, Inc. |
|
Clopidogrel |
Sanofi-Synthelabo |
| Colesevelam | Sankyo Pharma |
|
Cromolyn |
Pharmacia & Upjohn |
|
Cromolyn |
Bausch & Lomb |
|
Cytarabine |
SkyePharma Inc. |
|
Desflurane |
Baxter Healthcare |
| Desloratadine | Schering |
| Dexrazoxane | Pfizer Pharm |
|
Dichlorphenamide |
Merck |
|
Didanosine |
Bristol-Myers Squibb |
|
Dorzolamide |
Merck |
|
Efavirenz |
DuPont Pharmaceuticals |
| Eletriptan | Pfizer, Inc. |
| Emtricitabine | Triangle Pharmaceuticals |
|
Enalapril |
Merck |
| Enfuvirtide (T-20) | Hoffman-La Roche |
| Enoxaparin | Aventis |
| Epirubicin | Pharmacia & Upjohn |
| Eplerenone | Searle |
| Ertapenem | Merck |
|
Esmolol |
Baxter Pharmaceutical |
|
Esomeprazole |
AstraZeneca |
|
Etodolac |
Wyeth-Ayerst |
|
Famciclovir |
Novartis |
|
Famotidine |
Merck |
|
Felodipine |
Astra Pharmaceuticals |
|
Fenoldopam |
Elan Pharmaceuticals |
| Fentanyl | Anesta |
|
Fentanyl |
Janssen Pharmaceutica |
|
Fexofenadine |
Aventis |
|
Fluconazole |
Pfizer |
|
Fludarabine |
Berlex |
| Fluocinolone | Bausch & Lomb |
|
Fluoxetine |
Lilly |
|
Fluticasone |
Glaxo Wellcome, Inc. |
|
Fluvastatin |
Novartis |
|
Fluvoxamine |
Solvay Pharmaceuticals |
| Formoterol | Novartis |
|
Fosinopril |
Bristol-Myers Squibb |
|
Fosphenytoin |
Pfizer |
| Fulvestrant | AstraZeneca Pharmaceut |
|
Gabapentin |
Parke-Davis |
|
Gatifloxacin |
Bristol-Myers Squibb |
| Gatifloxacin | Allergan |
|
Gemcitabine |
Lilly |
|
Gemtuzumab |
Wyeth-Ayerst |
|
Gentamicin |
Schering |
|
Glatiramer |
Teva |
|
Glimepiride |
Aventis Pharm. |
| Glipizide/Metformin | Bristol-Myers Squibb |
|
Glyburide/Metformin |
Bristol-Myers Squibb |
| Granisetron | Hoffman La-Roche |
| Hydrocortisone | Atlanta, Inc. |
| Hydroxyurea | Bristol-Myers Squibb |
|
Ibuprofen |
McNeil Consumer Prod |
|
Ibuprofen |
Whitehall-Robbins |
| Ibuprofen/pseudoephedrine | McNeil Consumer Prod |
| Ibuprofen/pseudoephedrine | Whitehall-Robbins |
| Imatinib | Novartis |
| Imiquimod | 3M Pharmaceuticals |
|
Indinavir |
Merck |
|
Insulin aspart [rDNA origin] |
Novo Nordisk |
|
Insulin glargine |
Aventis |
|
Irbesartan |
Bristol-Myers Squibb |
|
Irinotecan |
Pharmacia & Upjohn |
|
Isotretinoin |
Hoffman-LaRoche, Inc |
|
Itraconazole |
Janssen Pharmaceutica |
|
Ketoconazole |
Janssen Pharmaceutica |
|
Ketorolac |
Allergan |
|
Labetalol |
Schering |
|
Lamivudine |
Glaxo Wellcome, Inc. |
|
Lamotrigine |
Glaxo Wellcome, Inc. |
|
Lansoprazole |
TAP Holdings, Inc. |
|
Leflunomide |
Hoechst Marion Roussel |
| Levalbuterol | Sepracor |
|
Levetiracetam |
UCB Pharma |
|
Levobetaxolol |
Alcon |
|
Levobunolol |
Allergan |
|
Levofloxacin |
R.W. Johnson |
| Levofloxacin | Santen |
|
Linezolid |
Pharmacia & UpJohn |
|
Lisinopril |
Zeneca Pharmaceuticals |
|
Lisinopril |
Merck |
| Lopinavir/Ritonavir | Abbott |
|
Loratadine |
Schering |
|
Losartan |
Merck |
|
Lovastatin |
Merck |
|
Mesalamine |
Procter & Gamble |
|
Metformin |
Bristol-Myers Squibb |
|
Methazolamide |
Wyeth-Ayerst |
| Methylphenidate | McNeil |
|
Metipranolol |
Bausch & Lomb |
|
Metoprolol |
Astra Zeneca |
|
Midazolam |
Hoffmann-La Roche |
|
Milrinone |
Sanofi Synthelabo, Inc. |
|
Minoxidil |
Pharmacia & UpJohn |
|
Mirtazapine |
Organon Inc. |
| Modafinil | Cephalon, Inc. |
|
Moexipril |
Schwarz Pharma |
|
Mometasone |
Schering |
|
Montelukast |
Merck & Co., Inc. |
| Morphine | Elan Drug Delivery |
| Morphine | Faulding |
| Moxifloxacin | Alcon Universal, Ltd. |
|
Nabumetone |
SmithKline Beecham |
|
Nateglinide |
Novartis |
|
Nefazodone |
Bristol-Myers Squibb |
|
Nelfinavir |
Agouron Pharmaceutical |
|
Nevirapine |
Boehringer Ingelheim |
|
Nicotine |
SmithKline Beecham |
|
Nizatidine |
Reliant |
|
Norfloxacin |
Merck |
| Norgestimate/ethinyl estradiol | R.W. Johnson |
| Octreotide | Novartis |
|
Ofloxacin |
Allergan |
|
Olanzapine |
Lilly |
| Olmesartan | Sankyo Pharma, Inc. |
|
Omeprazole |
Astra Zeneca |
|
Ondansetron |
Glaxo Wellcome |
|
Orlistat |
Hoffman-LaRoche |
|
Oseltamivir |
Roche |
|
Oxaprozin |
Searle |
|
Oxcarbazepine |
Novartis |
| Oxybutynin | Alza |
|
Oxybutynin |
Watson Labs |
|
Oxycodone |
Purdue Pharma L.P. |
|
Pantoprazole |
Wyeth-Ayerst |
|
Paricalcitol |
Abbott |
|
Paroxetine |
SmithKline Beecham |
| Pegvisomant | Pharmacia & Upjohn |
|
Pemirolast |
Santen |
| Pimecrolimus | Novartis |
| Pioglitazone | Takeda |
|
Polyethylene Glycol |
Braintree Labs |
|
Pravastatin |
Bristol-Myers Squibb |
|
Propofol |
Zeneca Pharmaceuticals |
| Quetiapine Fumerate | AstraZeneca |
|
Quinapril |
Parke-Davis |
|
Rabeprazole |
Eisai, Inc. |
|
Ramipril |
King Pharm. |
|
Ranitidine |
GlaxoWellcome, Inc. |
|
Remifentanil |
Glaxo Wellcome, Inc. |
|
Repaglinide |
Novo Nordisk |
|
Ribavirin/Interferon alfa-2B, recombinant |
Schering |
|
Rifapentine |
Hoechst-Marion Roussel |
| Risedronate | Procter & Gamble |
| Risperidone | Janssen Research |
|
Ritonavir |
Abbott Laboratories |
|
Rocuronium |
Organon |
|
Rofecoxib |
Merck |
|
Ropivacaine |
Astra Zeneca |
|
Rosiglitazone |
SmithKline Beecham |
| Rosiglitazone | S.B. Pharmco Puerto Rico, Inc. |
|
Salmeterol |
Glaxo Wellcome, Inc. |
|
Saquinavir |
Hoffman-La Roche Inc. |
|
Sertraline |
Pfizer Pharmaceuticals |
|
Sevelamer |
GelTex |
|
Sevoflurane |
Abbott |
|
Sibutramine |
Knoll Pharmaceutical |
|
Sildenafil |
Pfizer |
|
Simvastatin |
Merck |
|
Sirolimus |
Wyeth-Ayerst |
| Sodium ferric gluconate complex | Watson Laboratories |
|
Somatropin [rDNA origin] |
Serono Laboratories |
|
Sotalol |
Berlex Lab., Inc. |
|
Stavudine |
Bristol-Myers Squibb |
|
Sumatriptan |
Glaxo Wellcome, Inc. |
| Tacrolimus | R-Tech Ueno (USA) |
|
Tamoxifen |
Astra Zeneca |
|
Temozolomide |
Schering |
|
Tenofovir |
Gilead Sciences |
|
Terbinafine |
Novartis |
| Testosterone | Unimed Pharmaceuticals |
|
Timolol |
Merck |
|
Timolol |
Falcon Pharmaceuticals |
|
Timolol |
Santen |
| Tobramycin | Alcon Laboratories |
|
Tobramycin |
Falcon Pharmaceuticals |
|
Tolterodine |
Pharmacia & Upjohn |
| Topiramate | The R.W. Johnson |
|
Topotecan |
SmithKline Beecham |
|
Tramadol |
R.W. Johnson |
|
Valacyclovir |
GlaxoSmithKline |
|
Valganciclovir |
Roche |
| Valproate | Abbott Laboratories |
|
Valsartan |
Novartis Pharmaceuticals |
|
Venlafaxine |
Wyeth-Ayerst |
|
Verapamil |
Elan Pharmaceuticals |
|
Vinorelbine |
Glaxo Wellcome |
|
Voriconazole |
Pfizer |
|
Zafirlukast |
Zeneca Pharmaceuticals |
|
Zanamivir |
Glaxo Wellcome, Inc |
| Ziprasidone | Pfizer |
| Zoledronic acid | Novartis Pharmaceuticals |
|
Zolmitriptan |
Zeneca Pharmaceuticals |
|
Zonisamide |
Elan Pharmaceuticals |
Last Updated: November 10, 2004