Drugs

Written Requests Issued

  

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. Sometimes FDA obtains information after issuing a Written Request that causes the Agency 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 This list is not updated to indicate when a Written Request has been rescinded.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 = 391*
Active Moiety
Sponsor
Abacavir Glaxo Wellcome, Inc.
Abatacept Bristol-Myers Squibb Company
Acamprosate Forest Labs
Acetaminophen  Cadence Pharmaceuticals
Acetazolamide Wyeth-Ayerst
Adefovir Gilead
Albuterol Dey
Albuterol GlaxoSmithKline
Alendronate Merck
Alfuzosin Sanofi-Aventis U.S. LLC
Aliskiren Novartis
Almotriptan Pharmacia & Upjohn
Alogliptin Takeda Pharmaceuticals U.S.A., Inc.
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
Apremilast Celgene Corporation
Aprepitant/Fosaprepitant Merck & Company, Inc.
Argatroban Encysive
Aripiprazole Otsuka
Atazanavir Bristol-Myers Squib
Atomoxetine Lilly
Atorvastatin Warner-Lambert
Atovaquone/Proguanil Glaxo Wellcome, Inc.
Azelastine ASTA Medica
Azelastine Meda Pharmaceuticals, Inc.
Azilsartan medoxomil Takeda Pharmaceuticals U.S.A., Inc.
Azithromycin  Pfizer
Baclofen Schwarz
Balsalazide Salix Pharm.
Beclomethasone Schering
Beclomethasone 3M
Benazepril Novartis
Bendamustine Cephalon, Inc.
Besifloxacin Bausch & Lomb, Inc.
Betamethasone Schering
Betaxolol Lorex Pharmaceuticals
Betaxolol Alcon
Bicalutamide AstraZenenca Pharm.
Bisoprolol Wyeth-Ayerst
Bivalirudin Meds Co.
Boceprevir  Schering-Plough
Bortezomib Millenium Pharm
Brimonidine Allergan, Inc.
Brinzolamide Alcon
Budesonide AstraZeneca
Budesonide/Formoterol AstraZeneca
Buprenorphine Reckitt Benckiser Pharm
Buproprion Glaxo Wellcome, Inc
Buspirone Bristol-Myers Squibb
Busulfan Orphan Medical
C-Urea Meretek
Cabazitaxel  Sanofi-Aventis
Calcipotriene Leo Pharm
Calcitriol Abbott
Canagliflozin Janssen Pharmaceuticals, Inc.
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.
Clobazam Lundbeck, LLC
Clofarabine ILEX Products, Inc.
Clopidogrel Sanofi-Synthelabo
Cobicistat Gilead Sciences, Inc.
Colchicine, USP AR Holding Co., Inc.
Colesevelam Sankyo Pharma
Conivaptan Astrellas Pharma
Crizotinib  Pfizer, Inc.
Cromolyn Pharmacia & Upjohn
Cromolyn Bausch & Lomb
Cysteamine Raptor Therapeutics, Inc.
Cytarabine SkyePharma Inc.
Dactinomycin Merck & Company, Inc.
Daptomycin Cubist Pharmaceuticals, Inc.
Darbepoetin Amgen, Inc.
Darifenacin Novartis Pharmaceuticals Corp.
Darunavir Tibotec, Inc.
Dasatinib BMS
Decitabine Eisai medical Research, Inc.
Denosumab Amgen, Inc.
Desflurane Baxter Healthcare
Desloratadine Schering
Desvenlafaxine Wyeth
Dexmedetomidine Hospira, Inc.
Dexmethylphenidate Novartis Pharm
Dexrazoxane Pfizer Pharm
Dichlorphenamide Merck
Diclofenac Novartis
Diclofenac  Xanodyne Pharm
Didanosine Bristol-Myers Squibb
Difluprednate Sirion Therapeutics, Inc.
Dihydroergotamine Valeant
Divalproex Abbott Laboratories
Divalproex (valproate) Abbott Laboratories
Docetaxel Sanofi-Aventis, U.S., Inc.
Dolutegravir New ViiV Healthcare
Dorzolamide Merck
Duloxetine Eli Lilly & Co.
Efavirenz DuPont Pharmaceuticals
Eletriptan Pfizer, Inc.
Eltrombopag GlaxoSmithKline
Elvitegravir Gilead Sciences, 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
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
Ferric Citrate Keryx Biopharmaceuticals, Inc.
Fesoterodine  Pfizer, Inc.
Fexofenadine Aventis
Fingolimod Novartis Pharmaceutical Corporation
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
Fospropofol  Eisai, Inc.
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
Griseofulvin Pedinol Pharmacal, Inc.
Guanfacine Shire Development, Inc.
Hydrocortisone Atlanta, Inc.
Hydrocortisone  Bristol-Myers
Hydromorphone  Mallinckrodt, Inc.
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
Ipilimumab  Bristol-Myers Squibb Company
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
Lenalidomide Celgene Corporation
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
Liraglutide Novo Nordisk, Inc.
Lisdexamfetamine Shire
Lisinopril Zeneca Pharmaceuticals
Lisinopril Merck
Lopinavir/Ritonavir Abbott
Loratadine Schering
Losartan Merck
Loteprednol Bausch & Lomb, Inc.
Lovastatin Merck
Lurasidone  Sunovion Pharmaceuticals, Inc.
Malathion Taro Pharm, USA, Inc.
Maraviroc Pfizer, Inc.
Meloxicam Boehringer Ingelheim
Memantine  Forest Research Institute
Meropenem AstraZeneca
Mesalamine Procter & Gamble
Metformin Bristol-Myers Squibb
Methazolamide Wyeth-Ayerst
Methylphenidate McNeil
Metipranolol Bausch & Lomb
Metoclopramide Schwarz
Metoprolol AstraZeneca
Micafungin Astellas Pharma US, Inc.
Miconazole  BioAlliance Pharma
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
Mometasone/Formoterol Merck Sharp & Dohme Corp.
Montelukast Merck & Co., Inc.
Morphine Elan Drug Delivery
Morphine Faulding
Moxifloxacin Alcon Universal, Ltd.
NAB-paclitaxel Celgene Corporation
Nabumetone SmithKline Beecham
Naproxen/Sumatriptan  Glaxo
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.
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
Palonosetron Helsinn Healthcare SA
Pantoprazole Wyeth-Ayerst
Paricalcitol Abbott
Paroxetine SmithKline Beecham
Peginesatide Affymax, Inc.
Pegvisomant Pharmacia & Upjohn
Pemetrexed Eli Lilly & Co.
Pemirolast Santen
Pimecrolimus Novartis
Pioglitazone Takeda
Polyethylene Glycol 3500 Braintree Laboratories, Inc.
Posaconazole Schering
Pramipexole  Boehringer-Ingelheim
Prasugrel  Eli Lilly & Co.
Pravastatin Bristol-Myers Squibb
Pregabalin Pfizer Global
Propofol Zeneca Pharmaceuticals
Quetiapine AstraZeneca
Quinapril Parke-Davis
Rabeprazole Eisai, Inc.
Raltegravir  Merck & Co., Inc.
Ramelteon Takeda Global Research
Ramipril King Pharm.
Ranitidine GlaxoWellcome, Inc.
Remifentanil Glaxo Wellcome, Inc.
Repaglinide Novo Nordisk
Ribavirin/Interferon alfa-2B, recombinant Schering
Rifampin Aventis Pharmaceuticals, Inc.
Rifapentine Hoechst-Marion Roussel
Rifaximin Salix Pharm
Rilpivirine  Janssen Prods
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.
Sapropterin  BioMarin Pharmaceutical, Inc.
Saquinavir Hoffman-La Roche Inc.
Sertraline Pfizer Pharmaceuticals
Sevelamer GelTex
Sevoflurane Abbott
Sibutramine Knoll Pharmaceutical
Sildenafil Pfizer
Simvastatin Merck
Sirolimus Wyeth-Ayerst
Sitagliptin Merck Sharp & Dohme Corp.
Sodium ferric gluconate complex Watson Laboratories
Sodium oxybate Jazz Pharmaceuticals
Solifenacin Astellas Pharma Global
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
Tapentadol Janssen Research & Development, LLC
Technetium Tc99m Sestamibi Bristol-Myers Squibb
Telaprevir  Vertex Pharmaceuticals, Inc.
Telbivudine Idenix Pharm
Temozolomide Schering
Temsirolimus Wyeth-Ayerst
Tenofovir Gilead Sciences
Terbinafine Novartis
Teriflunamide Sanofi-Aventis U.S., Inc.
Testosterone Unimed Pharmaceuticals
Tetrabenazine Biovail Technologies
Timolol Merck
Timolol Falcon Pharmaceuticals
Timolol Santen
Tipranavir Boehringer Ingelheim Pharm
Tizanidine  Acorda Therapeutics, Inc.
Tobramycin Alcon Laboratories
Tobramycin Falcon Pharmaceuticals
Tocilizumab Hoffmann-LaRoche, Inc.
Tolterodine Pharmacia & Upjohn
Tolvaptan Otsuka Pharmaceutical
Topiramate The R.W. Johnson
Topotecan SmithKline Beecham
Tramadol R.W. Johnson
Valacyclovir GlaxoSmithKline
Valganciclovir Roche
Valsartan Novartis Pharmaceuticals
Varenicline Pfizer
Venlafaxine Wyeth-Ayerst
Verapamil Elan Pharmaceuticals
Vigabatrin  Lundbeck, Inc.
Vilazodone Forest Labs
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

 

Page Last Updated: 06/12/2015
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