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 This list is not updated to indicate when a Written Request has been rescinded.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 = 362

Active Moiety	Sponsor
Abacavir	Glaxo Wellcome, Inc.
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
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
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
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
Conivaptan	Astrellas Pharma
Crizotinib	Pfizer, Inc.
Cromolyn	Pharmacia & Upjohn
Cromolyn	Bausch & Lomb
Cytarabine	SkyePharma 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.
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
Fesoterodine	Pfizer, Inc.
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
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
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
Irbesartan	Bristol-Myers Squibb
Irinotecan	Pharmacia & Upjohn
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
Liraglutide	Novo Nordisk, Inc.
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
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.
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
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
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
Technetium Tc99m Sestamibi	Bristol-Myers Squibb
Telaprevir	Vertex Pharmaceuticals, Inc.
Telbivudine	Idenix Pharm
Temozolomide	Schering
Temsirolimus	Wyeth-Ayerst
Tenofovir	Gilead Sciences
Terbinafine	Novartis
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
Valproate	Abbott Laboratories
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