Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018

Total Approved Active Moieties Issued a Written Request = 442

Active Moiety SponsorAbacavir Glaxo Wellcome, Inc.Abatacept Bristol-Myers Squibb CompanyAcamprosate Forest LabsAcetaminophen Cadence PharmaceuticalsAcetazolamide Wyeth-AyerstAdefovir Gilead SciencesAfatinib Boehringer Intelheim Pharmaceuticals, Inc.Albuterol Dey, L.P.Albuterol GlaxoSmithKlineAlendronate Merck Research LaboratoriesAlfuzosin Sanofi-Aventis U.S. LLCAliskiren Novartis PharmaceuticalsAlmotriptan Pharmacia & UpjohnAlogliptin Takeda Pharmaceuticals U.S.A., Inc.Alosetron Glaxo Wellcome, Inc.Alprazolam Pharmacia & Upjohn

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 This list is not updated to indicate when a Written Request has been rescinded.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Amiodarone Wyeth AyerstAmlexanox Block Drug Company, Inc.Amlodipine Pfizer, Inc.Amlodipine/Benazepril Novartis PharmaceuticalsAmmonium Lactate Westwood SquibbAmphetamine (mixed salts) Shire LaboratoriesAmprenavir Glaxo Wellcome, Inc.Anagrelide Shire LaboratoriesAnastrozole AstraZeneca Pharmaceuticals LPApixaban Bristol-Myers Squibb CompanyApremilast Celgene CorporationAprepitant/Fosaprepitant Merck & Company, Inc.Argatroban Encysive PharmaceuticalsAripiprazole Otsuka Pharmaceutical Co., Ltd.Asenapine Organon USA, Inc.Atazanavir Bristol-Myers SquibAtezolizuab Genentech, Inc.Atomoxetine Lilly Research LaboratoriesAtorvastatin Warner-Lambert Export, Ltd.Atovaquone/Proguanil Glaxo Wellcome, Inc.Azelastine ASTA Medica, Inc.Azelastine Meda Pharmaceuticals, Inc.Azilsartan medoxomil Takeda Pharmaceuticals U.S.A., Inc.Azithromycin PfizerBaclofen Schwarz Pharma, Inc.Balsalazide Salix PharmaceuticalsBeclomethasone Schering CorporationBeclomethasone 3M PharmaceuticalsBenazepril Novartis PharmaceuticalsBendamustine Cephalon, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Besifloxacin Bausch & Lomb, Inc.Betamethasone Schering CorporationBetaxolol Lorex PharmaceuticalsBetaxolol Alcon LaboratoriesBicalutamide AstraZeneca PharmaceuticalsBictegravir/Emtricitabine/Tenofovir Alafenamide(B/F/TAF) Gilead Sciences, Inc.Bisoprolol Wyeth-Ayerst LaboratoriesBivalirudin The Medicines CompanyBlinatumomab Amgen, Inc.Boceprevir Schering-PloughBortezomib Millenium PharmaceuticalsBosutinib Wyeth Pharmaceuticals, Inc.Brimonidine Allergan, Inc.Brinzolamide Alcon LaboratoriesBudesonide AstraZeneca Pharmaceuticals, L.P.Budesonide/Formoterol AstraZeneca Pharmaceuticals, L.P.Buprenorphine Reckitt Benckiser PharmaceuticalsBupropion Glaxo Wellcome, IncBuspirone Bristol-Myers Squibb CompanyBusulfan Orphan MedicalC-Urea Meretek Diagnostics, Inc.Cabazitaxel Sanofi-AventisCalcipotriene Leo PharmaceuticalsCalcitriol Abbott LaboratoriesCalcitriol Galderma LaboratoriesCanagliflozin Janssen Pharmaceuticals, Inc.Candesartan Astra PharmaceuticalsCapecitabine Hoffmann-La Roche, Inc.Carbamazepine Shire Development, Inc.Carboplatin Bristol-Myers Squibb Company

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Carfilzomib Onyx Therapeutics, Inc.Cariprazine Forest Research InstituteCarteolol CIBA Vision CorporationCarvedilol SmithKline Beecham PharmaceuticalsCaspofungin Merck Research LaboratoriesCelecoxib G.D. Searle & Co.Cerivastatin Bayer Corporation PharmaceuticalCetirizine Pfizer PharmaceuticalsCilostazol Otsuka Pharmaceutical Co., Ltd.Cimetidine SmithKline Beecham Cinacalcet Amgen, Inc.Ciprofloxacin Bayer CorporationCiprofloxacin Alcon LaboratoriesCisatracurium Glaxo Wellcome Citalopram Forest Laboratories, Inc.Clobazam Lundbeck, LLCClofarabine ILEX Products, Inc.Clopidogrel Sanofi-Synthelabo, Inc.Cobicistat Gilead Sciences, Inc.Cobimetinib Genentech, Inc.Colchicine, USP AR Holding Co., Inc.Colesevelam Sankyo Pharma DevelopmentConivaptan Astellas Pharma US, Inc.Crizotinib PfizerCromolyn Pharmacia & UpjohnCromolyn Bausch & Lomb Pharmaceuticals, Inc.Cysteamine Raptor Therapeutics, Inc.Cytarabine SkyePharma Inc.Dabrafenib Novartis Pharmaceuticals CorporationDactinomycin Merck & Company, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Daptomycin Cubist Pharmaceuticals, Inc.Darbepoetin Amgen, Inc.Darifenacin Novartis Pharmaceuticals CorporationDarunavir Tibotec, Inc.Dasatinib Bristol-Myers Squibb CompanyDecitabine Eisai Medical Research, Inc.Deferasirox Novartis Pharmaceuticals CorporationDeflazacort PTC Therapeutics, Inc.Denosumab Amgen, Inc.Desflurane Baxter Healthcare CorporationDesloratadine Schering CorporationDesvenlafaxine Wyeth Pharmaceuticals, Inc.Dexmedetomidine Hospira, Inc.Dexmethylphenidate Novartis PharmaceuticalsDexrazoxane Pfizer PharmaceuticalsDichlorphenamide Merck Research LaboratoriesDiclofenac Novartis Consumer Health, Inc.Diclofenac Xanodyne Pharmaceuticals, Inc.Didanosine Bristol-Myers Squibb CompanyDifluprednate Sirion Therapeutics, Inc.Divalproex Abbott LaboratoriesDivalproex(valproate) Abbott LaboratoriesDocetaxel Sanofi-Aventis, U.S., Inc.Dolutegravir ViiV HealthcareDorzolamide Merck Research LaboratoriesDulaglutide Eli Lilly and CompanyDuloxetine Eli Lilly & Co.Efavirenz DuPont Pharmaceuticals CompanyEfinaconazole Dow Pharmaceutical SciencesEletriptan Pfizer, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Eltrombopag GlaxoSmithKlineElvitegravir Gilead Sciences, Inc.Emtricitabine Triangle Pharmaceuticals, Inc.Enalapril Merck Research LaboratoriesEnfuvirtide Hoffman-La Roche, Inc.Enoxaparin Aventis Pharmaceuticals, Inc.Entecavir Bristol-Myers Squibb CompanyEribulin Eisai, Inc.Epirubicin Pharmacia & UpjohnEplerenone G.D. Searle and CompanyErlotinib OSI Pharmaceuticals, Inc.Ertapenem Merck & Co., Inc.Eslicarbazepine Sunovion Pharmaceutical, Inc.Esmolol Baxter Pharmaceuticals Products, Inc.Esomeprazole AstraZeneca Pharmaceuticals, LPEszopiclone Sepracor, Inc.Etodolac Wyeth-Ayerst ResearchEtravirine Tibotec, Inc.Everolimus Novartis Pharmaceuticals CorporationExenatide Amylin Pharmaceuticals, Inc.Ezetimibe MSP Singapore Co., LLCFamciclovir Novartis Pharmaceuticals CorporationFamotidine Merck & Company, Inc.Felodipine Astra Pharmaceuticals, L.P.Fenoldopam Elan PharmaceuticalsFentanyl Anesta CorporationFentanyl Janssen PharmaceuticalsFerric Citrate Keryx Biopharmaceuticals, Inc.Fesoterodine Pfizer, Inc.Fexofenadine Aventis Pharmaceuticals

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Fingolimod Novartis Pharmaceutical CorporationFluconazole Pfizer Pharmaceuticals GroupFludarabine Berlex LaboratoriesFluocinolone Bausch & Lomb Pharmaceuticals, Inc.Fluoxetine Eli Lilly and CompanyFluticasone Glaxo Wellcome, Inc.Fluvastatin Novartis Pharmaceuticals CorporationFluvoxamine Solvay PharmaceuticalsFormoterol Novartis Pharmaceuticals CorporationFosamprenavir GlaxoSmithKlineFosaprepitant MerckFosinopril Bristol-Myers Squibb CompanyFosphenytoin Pfizer, Inc.Fospropofol Eisai, Inc.Fulvestrant AstraZeneca Pharmaceuticals, LPGabapentin Parke-Davis Pharmaceutical ResearchGadopentetate Bayer HealthCare Pharmaceuticals, Inc.Gatifloxacin Bristol-Myers Squibb CompanyGatifloxacin Allergan, Inc.Gefitinib AstraZeneca, Pharmaceuticals, LPGemcitabine Lilly Research LaboratoriesGemtuzumab Wyeth-Ayerst Research Laboratories Gentamicin Schering CorporationGlatiramer TEVA Pharmaceuticals USAGlecaprevir/Pibrentasvir AbbVie, Inc.Glimepiride Aventis PharmaceuticalsGlipizide/Metformin Bristol-Myers Squibb CompanyGlyburide/Metformin Bristol-Myers Squibb CompanyGranisetron Hoffman La-Roche, Inc.Griseofulvin Pedinol Pharmacal, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Guanfacine Shire Development, Inc.Halobetasol Propionate Sun Pharmaceutical Industries, Inc.Hydrocortisone Atlanta, Inc.

Bristol-Myers Squibb Company Hydromorphone Mallinckrodt, Inc.Hydroxyurea Bristol-Myers Squibb CompanyIbuprofen McNeil Consumer Products CompanyIbuprofen Whitehall-RobbinsIbuprofen/pseudoephedrine McNeil Consumer Products CompanyIbuprofen/pseudoephedrine Whitehall-Robbins HealthcareIloperidone Novartis Pharmaceuticals CorporationImatinib Novartis Pharmaceuticals CorporationImiquimod 3M PharmaceuticalsIndinavir Merck Research LaboratoriesInsulin aspart [rDNA origin] Novo Nordisk Pharmaceuticals, Inc.Insulin glargine Aventis Pharmaceutical, Inc.Ipilimumab Bristol-Myers Squibb CompanyIrbesartan Bristol-Myers Squibb CompanyIrinotecan Pharmacia & UpjohnIsavuconazonium Astellas Pharma US, Inc.Isotretinoin Hoffman-LaRoche, Inc.Itraconazole Janssen Pharmaceutica ResearchIvabradine CorlanorIvacaftor Vertex PharmaceuticalIxabepilone Bristol-Myers Squibb CompanyKetoconazole Janssen Pharmaceutica ResearchKetorolac Allergan, Inc.Labetalol Schering CorporationLamivudine Glaxo Wellcome, Inc.Lamotrigine Glaxo Wellcome, Inc.

Hydrocortisone 

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Lansoprazole TAP Holdings, Inc.Ledipasvir Gilead Sciences, Inc.Leflunomide Hoechst Marion Roussel, Inc.Lenalidomide Celgene CorporationLevalbuterol Sepracor, Inc.Levetiracetam UCB Pharma, Inc.Levobetaxolol Alcon Laboratories, Inc.Levobunolol Allergan, Inc.Levocetirizine UCB, Inc.Levofloxacin R.W. JohnsonLevofloxacin Santen, Inc.Levomilnacipran Forest Laboratories, Inc.Levonorgestrel/ethinyl estradiol Duramed Research, Inc.Linaclotide Forest Laboratories, LLCLinezolid Pharmacia & UpJohnLiraglutide Novo Nordisk, Inc.Lisdexamfetamine ShireLisinopril Zeneca PharmaceuticalsLisinopril Merck & Co., Inc.Lithium RoxaneLomitapide AegerionLopinavir/Ritonavir Abbott LaboratoriesLoratadine Schering CorporationLorazepam Wyeth-Ayerst ResearchLorcaserin Eisai, Inc.Losartan Merck Research LaboratoriesLoteprednol Bausch & Lomb, Inc.Lovastatin Merck & Co., Inc.Lurasidone Sunovion Pharmaceuticals, Inc.Macitentan Actelion Clinical Res., Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Malathion Taro Pharm, USA, Inc.Maraviroc Pfizer, Inc.Meloxicam Boehringer Ingelheim PharmaceuticalsMemantine Forest Research InstituteMeropenem AstraZenecaMesalamine Procter & Gamble Pharmaceuticals, Inc.Mesalamine ShireMetformin Bristol-Myers Squibb CompanyMethazolamide Wyeth-Ayerst Laboratories Methotrexate Mayne Pharma (USA) Inc.Methylphenidate McNeil Consumer & Specialty Pharm.Metipranolol Bausch & LombMetoclopramide Schwarz Pharma, Inc.Metoprolol AstraZeneca, Pharmaceuticals, LPMicafungin Astellas Pharma US, Inc.Miconazole BioAlliance PharmaMidazolam Hoffmann-La Roche, Inc.Milnacipran Cypress Bioscience, Inc.Milrinone Sanofi Synthelabo, Inc.Minoxidil Pharmacia & Upjohn CompanyMirabegron Astellas Pharma Global Development, Inc.Mirtazapine Organon, Inc.Modafinil Cephalon, Inc.Moexipril Schwarz PharmaceuticalsMometasone Schering CorporationMometasone/Formoterol Merck Sharp & Dohme Corp.Montelukast Merck & Co., Inc.Morphine Elan Drug DeliveryMorphine Faulding PharmaceuticalsMotexafin Pharmacyclics

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Moxifloxacin Alcon Universal, Ltd.NAB-paclitaxel Celgene CorporationNabumetone SmithKline BeechamNateglinide Novartis PharmaceuticalsNefazodone Bristol-Myers Squibb CompanyNelfinavir Agouron Pharmaceuticals, Inc.Nevirapine Boehringer Ingelheim PharmaceuticalsNicardipine PDL BioPharma, Inc.Nicotine SmithKline BeechamNilotinib Novartis Pharmaceuticals Nitric Oxide INO TherapeuticsNivolumab Bristol-Myers Squibb CompanyNizatidine Reliant PharmaceuticalsNorfloxacin Merck & Co., Inc.Norgestimate/ethinyl estradiol R.W. Johnson Pharmaceutical ResearchOctreotideOfloxacin Allergan, Inc.Olanzapine Lilly Research LaboratoriesOlmesartan Sankyo Pharma, Inc.Olopatadine Alcon Research, Ltd.Omeprazole AstraZeneca Pharmaceuticals, LPOndansetron Glaxo Wellcome, Inc.Orlistat Hoffman-La Roche, Inc.Oseltamivir Hoffman-La Roche, Inc.Oxaliplatin Sanofi-Synthelabo, Inc.Oxaprozin SearleOxcarbazepine Novartis Pharmaceuticals CorporationOxybutynin Alza CorporationOxybutynin Watson Laboratories, Inc.Oxycodone Purdue Pharma L.P.

Novartis Pharmaceuticals Corporation

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Oxymorphone Endo PharmaceuticalsPaliperidone J&J PharmaceuticalsPalonosetron Helsinn Healthcare SAPantoprazole Wyeth-Ayerst LaboratoriesParicalcitol Abbott LaboratoriesParoxetine SmithKline Beecham PharmaceuticalsPeginesatide Affymax, Inc.Pegvisomant Pharmacia & Upjohn Co.Pemetrexed Eli Lilly & CompanyPemirolast Santen, Inc.Pimecrolimus Novartis Pharmaceutical CorporationPioglitazone Takeda Pharmaceuticals, Inc.Pitavastatin Kowa Research Institute, Inc.Plerixafor GenzymePolyethylene Glycol 3350 Braintree Laboratories, Inc.Pomalidomide Celgene CorporationPosaconazole Schering CorporationPramipexole Boehringer-IngelheimPrasugrel Eli Lilly & Co.Pravastatin Bristol-Myers SquibbPregabalin Pfizer GlobalPropofol Zeneca PharmaceuticalsQuetiapine AstraZeneca Pharmaceuticals, LPQuinapril Parke-Davis Pharmaceutical ResearchRabeprazole Eisai, Inc.Raltegravir Merck & Co., Inc.Ramelteon Takeda Global ResearchRamipril King PharmaceuticalsRanitidine GlaxoWellcome, Inc. Remifentanil Glaxo Wellcome, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Repaglinide Novo NordiskRibavirin/Interferon alfa-2B, recombinant Schering-Plough Research InstituteRifampin Aventis Pharmaceuticals, Inc.Rifapentine Hoechst Marion Roussel, Inc.Rifaximin Salix Pharmaceuticals, Inc.Rilpivirine Janssen ProdsRisedronate Procter & Gamble PharmaceuticalsRisperidone Janssen Research FoundationRitonavir Abbott LaboratoriesRivaroxaban Janssen Research & Development, LLCRizatriptanRocuronium Organon, Inc.Rofecoxib Merck & Co., Inc.Ropivacaine AstraZeneca Pharmaceuticals, LPRosiglitazone SmithKline Beecham PharmaceuticalsRosiglitazone S.B. Pharmco Puerto Rico, Inc.Rosuvastatin AstraZeneca Pharmaceuticals, LPRufinamide Eisai, Inc.Ruxolitinib JakafindaSacubitril/Valsartan Novartis Pharmaceuticals Corp.Salmeterol Glaxo Wellcome, Inc.Sapropterin BioMarin Pharmaceutical, Inc.Saquinavir Hoffman-La Roche Inc.Sertraline Pfizer PharmaceuticalsSevelamer GelTex Pharmaceuticals, Inc.Sevoflurane Abbott LaboratoriesSibutramine Knoll PharmaceuticalsSildenafil Pfizer, Inc.Simvastatin Merck & Co., Inc.Sirolimus Wyeth-Ayerst Research

Merck Research Laboratories

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Sitagliptin Merck Sharp & Dohme Corp.Sodium ferric gluconate complex Watson Laboratories, Inc.Sodium Nitroprusside Abbott LaboratoriesSodium oxybate Jazz PharmaceuticalsSofosbuvir Gilead Sciences, Inc.Solifenacin Astellas Pharma GlobalSomatropin [rDNA origin] Serono LaboratoriesSotalol Berlex Laboratories, Inc.Stavudine Bristol-Myers SquibbSugammadex Organon USA, Inc.Sumatriptan Glaxo Wellcome, Inc.Sumatriptan/naproxen Pozen, Inc.Sunitinib C.P. Pharmaceuticals Intl c/o Pfizer, Inc.Tacrolimus R-Tech Ueno (USA), Inc.Tadalafil Eli Lilly and CompanyTamoxifen AstraZeneca PharmaceuticalsTamsulosin Boehringer Ingelheim PharmaceuticalsTapentadol Janssen Research & Development, LLCTavaborole Anacor Pharmaceuticals, Inc.Tbo-filgrastin Teva Branded Pharmaceutical Products R&D, Inc.Technetium Tc99m Sestamibi Bristol-Myers Squibb Medical ImagingTeduglutide NPS Pharmaceuticals, Inc.Telaprevir Vertex Pharmaceuticals, Inc.Telbivudine Idenix Pharmaceuticals Inc.Temozolomide Schering CorporationTemsirolimus Wyeth-Ayerst Research Laboratories Tenofovir Gilead Sciences, Inc.Terbinafine Novartis Pharmaceuticals CorporationTeriflunamide Sanofi-Aventis U.S., Inc.Testosterone Unimed Pharmaceuticals, Inc.

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Tetrabenazine Biovail Technologies, Ltd.Timolol Merck Research LaboratoriesTimolol Falcon PharmaceuticalsTimolol Santen IncorporatedTiotropium Bromide Boehringer IngelheimTipranavir Boehringer Ingelheim PharmaceuticalsTizanidine Acorda Therapeutics, Inc.Tobramycin Alcon LaboratoriesTobramycin Falcon PharmaceuticalsTocilizumab Hoffmann-LaRoche, Inc.Tofacitinib P.F. Prism CVTolterodine Pharmacia & Upjohn CompanyTolvaptan Otsuka Pharmaceutical Company, Ltd.Topiramate The R.W. JohnsonTopotecan SmithKline BeechamTramadol R.W. JohnsonTrametinib Novartis Pharmaceuticals CorporationValacyclovir GlaxoSmithKlineValganciclovir Roche PharmaceuticalsValsartan Novartis PharmaceuticalsVarenicline Pfizer, Inc.Velpatasvir(VEL) Gilead Sciences, Inc.Venlafaxine Wyeth-Ayerst Laboratories Verapamil Elan Pharmaceutical Research Corp.Vigabatrin Lundbeck, Inc.Vilazodone Forest LabsVinorelbine Glaxo Wellcome, Inc.Voriconazole Pfizer Global Research & DevelopmentVortioxetine Takeda Pharms, USAZafirlukast Zeneca Pharmaceuticals

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Active Moiety Sponsor

Zanamivir Glaxo Wellcome, IncZiprasidone Pfizer, Inc.Zoledronic acid Novartis Pharmaceuticals CorporationZolmitriptan Zeneca PharmaceuticalsZolpidem Sanofi-Synthelabo ResearchZonisamide Elan Pharmaceuticals, Inc.

New*

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018

Date Issued8/20/19989/13/201311/9/20058/24/200710/15/19994/12/20024/7/2017

10/30/200112/31/200110/27/20002/21/20065/13/200810/5/200110/1/20134/7/20005/21/2003

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued11/5/19993/23/20002/4/1999

12/19/20012/22/19995/6/20034/7/19993/27/20035/9/20013/24/20175/29/20152/2/20094/2/20032/11/20039/22/20098/2/20018/10/201610/10/20012/16/19991/16/20014/16/19999/6/201312/6/20127/31/20034/30/200412/17/20016/24/199912/31/20015/27/19991/19/2010

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued1/13/20117/16/19992/11/19993/5/20044/17/20035/26/201712/23/19985/7/2007

11/12/201410/14/20114/27/20107/30/20156/25/199910/15/199912/14/19981/28/20114/12/20067/21/200010/9/19983/27/20006/10/20043/20/20122/20/20079/17/199910/13/20103/8/20143/15/19993/16/20059/7/20054/11/2001

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued3/17/20052/3/2017

10/15/199912/23/19981/26/20014/24/20002/29/20009/3/1999

12/17/200110/13/20005/5/20105/12/199910/22/19993/17/19994/28/19999/23/20133/7/2003

10/15/20013/27/20145/27/20173/30/20108/31/20046/14/201111/28/201111/24/19986/25/19998/19/20132/4/20003/1/20168/3/2004

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued5/24/201310/2/20147/30/200711/17/20069/17/20076/19/200912/17/20149/18/201711/30/201212/31/20016/6/20002/10/20093/14/20071/3/20076/17/200410/15/19994/30/20092/22/20118/5/19992/18/20091/31/20068/9/20026/11/20073/3/20106/24/19998/31/20166/23/20069/17/19984/17/20157/14/2004

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued1/25/20102/9/20157/16/199910/24/19981/9/20013/7/2003

11/28/20067/8/20162/19/20028/17/200011/27/20005/15/20007/8/20169/30/199912/31/20018/2/20062/3/19994/3/20084/25/20003/29/20064/15/20049/10/20018/3/1999

12/31/19984/14/199912/23/20037/15/19995/29/201511/14/20113/17/2000

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued3/20/201312/31/200111/9/20014/12/20014/12/19996/25/199912/4/200111/30/199912/31/200112/26/20012/2/20092/3/1999

12/17/19981/13/201210/21/200210/9/19981/26/20095/18/200110/4/200112/4/20001/9/20011/10/200111/1/19991/3/20002/3/2017

12/31/20016/18/20021/31/200112/19/20029/30/2005

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued10/30/200911/29/201712/12/200310/14/20053/15/20113/22/20026/8/19986/8/19989/7/19995/30/20005/13/20109/12/200012/28/20016/25/199912/14/199912/23/19987/7/2014

12/23/19981/22/200110/24/20176/22/20092/9/19994/4/20153/14/20166/22/20074/26/19995/10/200012/23/199811/25/199812/17/1998

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued8/26/19999/2/20163/30/19999/13/20143/14/20008/21/200110/15/199910/15/19992/3/2009

10/22/199912/20/20019/5/20148/14/20053/11/201612/22/19999/13/20126/3/2014

12/23/199812/23/19989/26/20031/20/20153/31/199910/15/19987/5/2002

10/24/20177/1/19994/26/20132/3/19994/20/20124/13/2016

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued4/13/201611/28/200611/22/20041/25/20129/10/200411/30/20015/2/20146/9/1999

10/15/19997/20/20066/25/200310/15/19997/20/200510/19/19995/23/20073/8/20127/20/19982/2/20091/21/200011/8/20003/18/20164/28/19996/17/20043/15/19993/17/19997/23/20123/4/19993/28/20033/28/200312/27/2001

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued6/26/200010/29/20143/19/199912/31/20014/28/19993/29/19999/11/19989/18/200712/4/19986/19/20094/30/20109/11/20146/22/200111/1/199911/12/20021/7/2004

10/22/199911/30/20013/6/20017/19/20077/1/19996/26/20018/9/20003/1/2000

12/19/20042/3/19992/28/200011/30/20005/14/200411/4/1998

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued3/16/200711/2/20067/23/201012/31/20012/22/20014/28/19991/4/20135/23/200310/5/20012/18/19999/27/19994/3/200211/2/20166/29/201512/27/200111/20/20152/28/20082/13/200912/19/20128/4/19996/8/20054/2/19992/11/200312/23/199812/31/20018/18/20066/2/2011

12/19/20018/26/199812/17/1998

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued

2/1/20001/25/19999/30/20036/19/19984/15/20037/30/20084/19/200211/25/20024/16/19996/8/20173/6/2009

12/31/20015/7/20013/2/20002/1/2000

12/15/20033/7/20066/21/200012/11/20153/2/20175/20/19991/14/20084/9/19994/28/19991/15/20023/2/20006/1/1999

12/17/20018/31/19999/15/1999

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued11/16/20128/9/20027/8/20023/10/20149/2/20167/27/20126/28/20001/15/19998/20/199910/28/20164/24/20146/29/200710/23/20064/19/200011/6/20064/5/20001/10/20067/8/20134/17/20159/21/201712/17/20046/12/201510/7/201112/1/20061/9/20011/12/200112/21/20012/28/20013/7/20136/21/2002

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued7/30/20107/6/1999

10/15/199910/15/19992/12/20161/22/200312/20/201210/22/199910/22/199911/15/20128/12/20151/23/20016/15/20117/9/20045/16/20003/30/19993/1/20168/2/20016/20/200112/19/20006/12/20079/2/20164/28/19992/3/19998/25/201111/20/20121/9/2001

12/21/20019/24/20151/4/1999

Approved Active Moieties to which FDAhas issued a Written Request for Pediatric Studies under

Section 505A of the Federal Food, Drug, and Cosmetic Act - May 2018Date Issued12/29/19982/11/20038/19/20023/26/199912/27/20055/21/2001