|
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 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when a Written Request has been rescinded.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 = 301
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 |
Betamethasone |
Schering |
Betaxolol |
Lorex Pharmaceuticals |
Betaxolol |
Alcon |
Bicalutamide |
AstraZenenca Pharm. |
Bisoprolol |
Wyeth-Ayerst |
Bivalirudin |
Meds Co. |
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 |
Ciprofloxacin |
Bayer |
Ciprofloxacin |
Alcon |
Cisatracurium |
Glaxo Wellcome |
Citalopram |
Forest Laboratories,
Inc. |
Clofarabine |
ILEX Products, Inc. |
Clopidogrel |
Sanofi-Synthelabo |
Colesevelam |
Sankyo Pharma |
Cromolyn |
Pharmacia & Upjohn |
Cromolyn |
Bausch & Lomb |
Cytarabine |
SkyePharma Inc. |
Darunavir |
Tibotec, Inc. |
Desflurane |
Baxter Healthcare |
Desloratadine |
Schering |
Dexmedetomidine |
Hospira, Inc. |
Dexmethylphenidate |
Novartis Pharm |
Dexrazoxane |
Pfizer Pharm |
Dichlorphenamide |
Merck |
Didanosine |
Bristol-Myers Squibb |
Divalproex |
Abbott |
Docetaxel |
Sanofi-Aventis, U.S.,
Inc. |
Dorzolamide |
Merck |
Duloxetine |
Eli Lilly & Co. |
Efavirenz |
DuPont Pharmaceuticals |
Eletriptan |
Pfizer, Inc. |
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 |
Etodolac |
Wyeth-Ayerst |
Etravirine |
Tibotec, Inc. |
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 |
Fosinopril |
Bristol-Myers Squibb |
Fosphenytoin |
Pfizer |
Fulvestrant |
AstraZeneca Pharmaceut |
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 |
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 |
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 |
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. |
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 |
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. |
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 |
Rocuronium |
Organon |
Rofecoxib |
Merck |
Ropivacaine |
AstraZeneca |
Rosiglitazone |
SmithKline Beecham |
Rosiglitazone |
S.B. Pharmco Puerto
Rico, Inc. |
Rosuvastatin |
AstraZeneca Pharm LP |
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 |
Back to Top
Back to Pediatrics
Date created: July 7, 2005; Last updated: August 7, 2008 |
|