NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since 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 This list is not updated to indicate when a Written Request has been rescinded.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 = 323
| Active Moiety |
Sponsor |
| Abacavir |
Glaxo Wellcome, Inc. |
| Acamprosate |
Forest Labs |
| Acetazolamide |
Wyeth-Ayerst |
| Adefovir |
Gilead |
| Albuterol |
Dey |
| Albuterol |
GlaxoSmithKline |
| Alendronate |
Merck |
| Alfuzosin |
Sanofi-Aventis U.S. LLC |
| Aliskiren |
Novartis |
| 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 |
AstraZeneca |
| Argatroban |
Encysive |
| 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 |
| Bendamustine |
Cephalon, Inc. |
| Betamethasone |
Schering |
| Betaxolol |
Lorex Pharmaceuticals |
| Betaxolol |
Alcon |
| Bicalutamide |
AstraZenenca Pharm. |
| Bisoprolol |
Wyeth-Ayerst |
| Bivalirudin |
Meds Co. |
| Bortezomib |
Millenium Pharm |
| Brimonidine |
Allergan, Inc. |
| Brinzolamide |
Alcon |
| Budesonide |
AstraZeneca |
| Buprenorphine |
Reckitt Benckiser Pharm |
| Buproprion |
Glaxo Wellcome, Inc |
| Buspirone |
Bristol-Myers Squibb |
| Busulfan |
Orphan Medical |
| C-Urea |
Meretek |
| Calcipotriene |
Leo Pharm |
| Calcitriol |
Abbott |
| Candesartan |
Astra Pharmaceuticals |
| Capecitabine |
HLR |
| Carbamazepine |
Shire |
| Carboplatin |
Bristol-Myers Squibb |
| Carteolol |
CIBA |
| Carvedilol |
SmithKline Beecham |
| Caspofungin |
Merck |
| Celecoxib |
Searle |
| Cerivastatin |
Bayer |
| Cetirizine |
Pfizer |
| Cilostazol |
Otsuka |
| Cimetidine |
SmithKline Beecham |
Cinacalcet  |
Amgen, Inc. |
| Ciprofloxacin |
Bayer |
| Ciprofloxacin |
Alcon |
| Cisatracurium |
Glaxo Wellcome |
| Citalopram |
Forest Laboratories, Inc. |
| Clofarabine |
ILEX Products, Inc. |
| Clopidogrel |
Sanofi-Synthelabo |
| Colchicine, USP |
AR Holding Co., Inc. |
| Colesevelam |
Sankyo Pharma |
| Cromolyn |
Pharmacia & Upjohn |
| Cromolyn |
Bausch & Lomb |
| Cytarabine |
SkyePharma Inc. |
| Darunavir |
Tibotec, Inc. |
| Decitabine |
Eisai medical Research, Inc. |
| Desflurane |
Baxter Healthcare |
| Desloratadine |
Schering |
| Dexmedetomidine |
Hospira, Inc. |
| Desvenlafaxine |
Wyeth |
| Dexmethylphenidate |
Novartis Pharm |
| Dexrazoxane |
Pfizer Pharm |
| Dichlorphenamide |
Merck |
| *Diclofenac |
Novartis |
| Didanosine |
Bristol-Myers Squibb |
| Difluprednate |
Sirion Therapeutics, Inc. |
| Divalproex |
Abbott |
| Divalproex |
Abbott |
| Docetaxel |
Sanofi-Aventis, U.S., Inc. |
| Dorzolamide |
Merck |
| Duloxetine |
Eli Lilly & Co. |
| Efavirenz |
DuPont Pharmaceuticals |
| Eletriptan |
Pfizer, Inc. |
| Eltrombopag |
GlaxoSmithKline |
| Emtricitabine |
Triangle Pharmaceuticals |
| Enalapril |
Merck |
| Enfuvirtide |
Hoffman-La Roche |
| Enoxaparin |
Aventis |
| Entecavir |
BMS |
| Epirubicin |
Pharmacia & Upjohn |
| Eplerenone |
Searle |
| Erlotinib |
OSI Pharm |
| Ertapenem |
Merck |
| Esmolol |
Baxter Pharmaceutical |
| Esomeprazole |
AstraZeneca |
| Eszopiclone |
Sepracor |
| Etodolac |
Wyeth-Ayerst |
| Etravirine |
Tibotec, Inc. |
| Everolimus |
Novartis |
| Exenatide |
Amylin Pharmaceuticals |
| Ezetimibe |
MSP Singapore |
| 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 |
| Fosamprenavir |
GlaxoSmithKline |
| Fosaprepitant |
Merck |
| Fosinopril |
Bristol-Myers Squibb |
| Fosphenytoin |
Pfizer |
| Fulvestrant |
AstraZeneca Pharmaceut |
| Gadopentetate |
Bayer Health Care Pharm, Inc. |
| Gabapentin |
Parke-Davis |
| Gatifloxacin |
Bristol-Myers Squibb |
| Gatifloxacin |
Allergan |
| Gefitinib |
AstraZeneca |
| 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 |
| Guanfacine |
Shire Development, Inc. |
| Hydrocortisone |
Atlanta, Inc. |
| Hydrocortisone |
Bristol-Myers |
| Hydroxyurea |
Bristol-Myers Squibb |
| Ibuprofen |
McNeil Consumer Prod |
| Ibuprofen |
Whitehall-Robbins |
| Ibuprofen/pseudoephedrine |
McNeil Consumer Prod |
| Ibuprofen/pseudoephedrine |
Whitehall-Robbins |
| Iloperidone |
Novartis |
| 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 |
| Levocetirizine |
UCB, Inc. |
| Levofloxacin |
R.W. Johnson |
| Levofloxacin |
Santen |
| Levonorgestrel/ethinyl estradiol |
Duramed Research, Inc. |
| Linezolid |
Pharmacia & UpJohn |
| Lisinopril |
Zeneca Pharmaceuticals |
| Lisinopril |
Merck |
| Lopinavir/Ritonavir |
Abbott |
| Loratadine |
Schering |
| Losartan |
Merck |
| Loteprednol |
Bausch & Lomb, Inc. |
| Lovastatin |
Merck |
| Malathion |
Taro Pharm, USA, Inc. |
| Maraviroc |
Pfizer, Inc. |
| Meloxicam |
Boehringer Ingelheim |
| Mesalamine |
Procter & Gamble |
| Metformin |
Bristol-Myers Squibb |
| Methazolamide |
Wyeth-Ayerst |
| Methylphenidate |
McNeil |
| Metipranolol |
Bausch & Lomb |
| Metoclopramide |
Schwarz |
| Metoprolol |
AstraZeneca |
| Micafungin |
Astellas Pharma US, Inc. |
| Milnacipran |
Cypress Bioscience, Inc. |
| 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 |
| Nicardipine |
PDL BioPharma, Inc. |
| Nicotine |
SmithKline Beecham |
| Nilotinib |
Novartis Pharmaceutical |
| Nitric Oxide |
INO Therapeutics |
| Nizatidine |
Reliant |
| Norfloxacin |
Merck |
| Norgestimate/ethinyl estradiol |
R.W. Johnson |
| Octreotide |
Novartis |
| Ofloxacin |
Allergan |
| Olanzapine |
Lilly |
| Olmesartan |
Sankyo Pharma, Inc. |
| Olmesartan |
Sankyo Pharma, Inc. |
| Olopatadine |
Alcon Research, Ltd. |
| Omeprazole |
AstraZeneca LP |
| Ondansetron |
Glaxo Wellcome |
| Orlistat |
Hoffman-LaRoche |
| Oseltamivir |
Roche |
| Oxaliplatin |
Sanofi-Synthelabo, Inc. |
| Oxaprozin |
Searle |
| Oxcarbazepine |
Novartis |
| Oxybutynin |
Alza |
| Oxybutynin |
Watson Labs |
| Oxycodone |
Purdue Pharma L.P. |
| Oxymorphone |
Endo Pharm |
| Paliperidone |
J&J Pharm |
| Pantoprazole |
Wyeth-Ayerst |
| Paricalcitol |
Abbott |
| Paroxetine |
SmithKline Beecham |
| Pegvisomant |
Pharmacia & Upjohn |
| Pemetrexed |
Eli Lilly & Co. |
| Pemirolast |
Santen |
| Pimecrolimus |
Novartis |
| Pioglitazone |
Takeda |
| Polyethylene Glycol |
Braintree Labs |
| Posaconazole |
Schering |
| Pravastatin |
Bristol-Myers Squibb |
| Pregabalin |
Pfizer Global |
| Propofol |
Zeneca Pharmaceuticals |
| Quetiapine |
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 |
| Rifaximin |
Salix Pharm |
| Risedronate |
Procter & Gamble |
| Risperidone |
Janssen Research |
| Ritonavir |
Abbott Laboratories |
| Rizatriptan |
Merck |
| Rocuronium |
Organon |
| Rofecoxib |
Merck |
| Ropivacaine |
AstraZeneca |
| Rosiglitazone |
SmithKline Beecham |
| Rosiglitazone |
S.B. Pharmco Puerto Rico, Inc. |
| Rosuvastatin |
AstraZeneca Pharm LP |
| Rufinamide |
Eisai |
| 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. |
| Sunitinib |
C.P. Pharm c/o Pfizer, Inc. |
| Tacrolimus |
R-Tech Ueno (USA) |
| Tadalafil |
Lilly Icos |
| Tamoxifen |
AstraZeneca |
| Tamsulosin |
Boehringer Ingelheim |
| Technetium Tc99m Sestamibi |
Bristol-Myers Squibb |
| Telbivudine |
Idenix Pharm |
| Temozolomide |
Schering |
| Tenofovir |
Gilead Sciences |
| Terbinafine |
Novartis |
| Testosterone |
Unimed Pharmaceuticals |
| Timolol |
Merck |
| Timolol |
Falcon Pharmaceuticals |
| Timolol |
Santen |
| Tipranavir |
Boehringer Ingelheim Pharm |
| 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 |
| Varenicline |
Pfizer |
| 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 |
| Zolpidem |
Sanofi-Synthelabo Research |
| Zonisamide |
Elan Pharmaceuticals |
|
NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since 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.