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  1. Development Resources

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 This list is not updated to indicate when a Written Request has been rescinded.

May 2019 Approved Active Moiety (XLS -  82 KB) 

Total Approved Active Moieties Issued a Written Request = 455

Active Moiety Sponsor Date Issued
Abacavir Glaxo Wellcome, Inc. 8/20/1998
Abatacept Bristol-Myers Squibb Company 9/13/2013
Acamprosate Forest Labs 11/9/2005
Acetaminophen Cadence Pharmaceuticals 8/24/2007
Acetazolamide Wyeth-Ayerst 10/15/1999
Adefovir Gilead Sciences 4/12/2002
Aflibercept  NEW
 
Regeneron Pharmaceuticals, Incorporated  6/4/2019
Afatinib Boehringer Intelheim Pharmaceuticals, Inc. 4/7/2017
Albuterol Dey, L.P. 10/30/2001
Albuterol  GlaxoSmithKline 12/31/2001
Alendronate Merck Research Laboratories 10/27/2000
Alfuzosin Sanofi-Aventis U.S. LLC 2/21/2006
Aliskiren Novartis Pharmaceuticals 5/13/2008
Almotriptan Pharmacia & Upjohn 10/5/2001
Alogliptin Takeda Pharmaceuticals U.S.A., Inc. 10/1/2013
Alosetron Glaxo Wellcome, Inc. 4/7/2000
Alprazolam Pharmacia & Upjohn 5/21/2003
Amiodarone Wyeth Ayerst 11/5/1999
Amlexanox Block Drug Company, Inc. 3/23/2000
Amlodipine Pfizer, Inc. 2/4/1999
Amlodipine/Benazepril Novartis Pharmaceuticals 12/19/2001
Ammonium Lactate Westwood Squibb 2/22/1999
Amphetamine (mixed salts) Shire Laboratories 5/6/2003
Amprenavir Glaxo Wellcome, Inc. 4/7/1999
Anagrelide  Shire Laboratories 3/27/2003
Anastrozole AstraZeneca Pharmaceuticals LP 5/9/2001
Apixaban Bristol-Myers Squibb Company 3/24/2017
Apremilast Celgene Corporation 5/29/2015
Aprepitant/Fosaprepitant Merck & Company, Inc. 2/2/2009
Argatroban  Encysive Pharmaceuticals 4/2/2003
Aripiprazole Otsuka Pharmaceutical Co., Ltd. 2/11/2003
Asenapine Organon USA, Inc. 9/22/2009
Atazanavir Bristol-Myers Squib 8/2/2001
Atezolizuab Genentech, Inc. 8/10/2016
Atomoxetine Lilly Research Laboratories 10/10/2001
Atorvastatin Warner-Lambert Export, Ltd. 2/16/1999
Atovaquone/Proguanil Glaxo Wellcome, Inc. 1/16/2001
Azelastine ASTA Medica, Inc. 4/16/1999
Azelastine Meda Pharmaceuticals, Inc. 9/6/2013
Azilsartan medoxomil Takeda Pharmaceuticals U.S.A., Inc. 12/6/2012
Azithromycin Pfizer 7/31/2003
Baclofen Schwarz Pharma, Inc. 4/30/2004
Balsalazide Salix Pharmaceuticals 12/17/2001
Beclomethasone Schering Corporation 6/24/1999
Beclomethasone 3M Pharmaceuticals 12/31/2001
Benazepril Novartis Pharmaceuticals 5/27/1999
Bendamustine Cephalon, Inc. 1/19/2010
Besifloxacin Bausch & Lomb, Inc. 1/13/2011
Betamethasone Schering Corporation 7/16/1999
Betaxolol Lorex Pharmaceuticals 2/11/1999
Betaxolol Alcon Laboratories 3/5/2004
Bicalutamide AstraZeneca Pharmaceuticals 4/17/2003
Bictegravir/Emtricitabine/Tenofovir Alafenamide(B/F/TAF) Gilead Sciences, Inc. 5/26/2017
Bisoprolol Wyeth-Ayerst Laboratories 12/23/1998
Bivalirudin The Medicines Company 5/7/2007
Blinatumomab Amgen, Inc. 11/12/2014
Boceprevir Schering-Plough 10/14/2011
Bortezomib Millenium Pharmaceuticals 4/27/2010
Bosutinib Wyeth Pharmaceuticals, Inc. 7/30/2015
Brexanolone Sage Therapeutics  3/20/2018
Brimonidine Allergan, Inc. 6/25/1999
Brinzolamide Alcon Laboratories 10/15/1999
Budesonide AstraZeneca Pharmaceuticals, L.P. 12/14/1998
Budesonide/Formoterol AstraZeneca Pharmaceuticals, L.P. 1/28/2011
Buprenorphine  Purdue Pharma L.P. 9/20/2011
Buprenorphine Reckitt Benckiser Pharmaceuticals 4/12/2006
Bupropion Glaxo Wellcome, Inc 7/21/2000
Buspirone Bristol-Myers Squibb Company 10/9/1998
Busulfan Orphan Medical 3/27/2000
C-Urea Meretek Diagnostics, Inc. 6/10/2004
Cabazitaxel Sanofi-Aventis 3/20/2012
Calcipotriene Leo Pharmaceuticals 2/20/2007
Calcitriol Abbott Laboratories 9/17/1999
Calcitriol Galderma Laboratories 10/13/2010
Canagliflozin Janssen Pharmaceuticals, Inc. 3/8/2014
Candesartan Astra Pharmaceuticals 3/15/1999
Capecitabine Hoffmann-La Roche, Inc. 3/16/2005
Carbamazepine Shire Development, Inc. 9/7/2005
Carboplatin Bristol-Myers Squibb Company 4/11/2001
Carfilzomib Onyx Therapeutics, Inc. 3/17/2005
Cariprazine Forest Research Institute 2/3/2017
Carteolol CIBA Vision Corporation 10/15/1999
Carvedilol SmithKline Beecham Pharmaceuticals 12/23/1998
Caspofungin Merck Research Laboratories 1/26/2001
Celecoxib G.D. Searle & Co. 4/24/2000
Cemiplimab-RWLC Regeneron Pharmaceuticals, Incorporated 12/3/2018
Cerivastatin Bayer Corporation Pharmaceutical 2/29/2000
Cetirizine Pfizer Pharmaceuticals 9/3/1999
Cilostazol Otsuka Pharmaceutical Co., Ltd. 12/17/2001
Cimetidine SmithKline Beecham  10/13/2000
Cinacalcet Amgen, Inc. 5/5/2010
Ciprofloxacin Bayer Corporation 5/12/1999
Ciprofloxacin Alcon Laboratories 10/22/1999
Cisatracurium Glaxo Wellcome  3/17/1999
Citalopram Forest Laboratories, Inc. 4/28/1999
Clobazam Lundbeck, LLC 9/23/2013
Clofarabine ILEX Products, Inc. 3/7/2003
Clopidogrel Sanofi-Synthelabo, Inc. 10/15/2001
Cobicistat Gilead Sciences, Inc. 3/27/2014
Cobimetinib Genentech, Inc. 5/27/2017
Colchicine, USP AR Holding Co., Inc. 3/30/2010
Colesevelam  Sankyo Pharma Development 8/31/2004
Conivaptan Astellas Pharma US, Inc. 6/14/2011
Crizotinib Pfizer 11/28/2011
Cromolyn  Pharmacia & Upjohn 11/24/1998
Cromolyn  Bausch & Lomb Pharmaceuticals, Inc. 6/25/1999
Cysteamine Raptor Therapeutics, Inc. 8/19/2013
Cytarabine SkyePharma Inc. 2/4/2000
Dabrafenib Novartis Pharmaceuticals Corporation 3/1/2016
Dactinomycin Merck & Company, Inc. 8/3/2004
Dapagliflozin  NEW AstraZeneca  3/26/2019
Daptomycin Cubist Pharmaceuticals, Inc. 5/24/2013
Darbepoetin Amgen, Inc. 10/2/2014
Darifenacin Novartis Pharmaceuticals Corporation 7/30/2007
Darunavir Tibotec, Inc. 11/17/2006
Dasatinib Bristol-Myers Squibb Company 9/17/2007
Decitabine Eisai Medical Research, Inc. 6/19/2009
Deferasirox Novartis Pharmaceuticals Corporation 12/17/2014
Deflazacort PTC Therapeutics, Inc. 9/18/2017
Denosumab Amgen, Inc. 11/30/2012
Desflurane Baxter Healthcare Corporation 12/31/2001
Desloratadine Schering Corporation 6/6/2000
Desvenlafaxine Wyeth Pharmaceuticals, Inc. 2/10/2009
Dexmedetomidine Hospira, Inc. 3/14/2007
Dexmethylphenidate Novartis Pharmaceuticals 1/3/2007
Dexrazoxane Pfizer Pharmaceuticals 6/17/2004
Dichlorphenamide Merck Research Laboratories 10/15/1999
Diclofenac Novartis Consumer Health, Inc. 4/30/2009
Diclofenac Xanodyne Pharmaceuticals, Inc. 2/22/2011
Didanosine Bristol-Myers Squibb Company 8/5/1999
Difluprednate Sirion Therapeutics, Inc. 2/18/2009
Divalproex Abbott Laboratories 1/31/2006
Divalproex(valproate) Abbott Laboratories 8/9/2002
Docetaxel Sanofi-Aventis, U.S., Inc. 6/11/2007
Dolutegravir ViiV Healthcare 3/3/2010
Dorzolamide Merck Research Laboratories 6/24/1999
Dulaglutide Eli Lilly and Company 8/31/2016
Duloxetine Eli Lilly & Co. 6/23/2006
Efavirenz DuPont Pharmaceuticals Company 9/17/1998
Efinaconazole Dow Pharmaceutical Sciences 4/17/2015
Eletriptan Pfizer, Inc. 7/14/2004
Eltrombopag GlaxoSmithKline 1/25/2010
Elvitegravir Gilead Sciences, Inc. 2/9/2015
Emtricitabine Triangle Pharmaceuticals, Inc. 7/16/1999
Enalapril  Merck Research Laboratories 10/24/1998
Enfuvirtide Hoffman-La Roche, Inc. 1/9/2001
Enoxaparin Aventis Pharmaceuticals, Inc. 3/7/2003
Entecavir Bristol-Myers Squibb Company 11/28/2006
Eribulin Eisai, Inc. 7/8/2016
Epirubicin Pharmacia & Upjohn 2/19/2002
Eplerenone G.D. Searle and Company 8/17/2000
Erlotinib OSI Pharmaceuticals, Inc. 11/27/2000
Ertapenem Merck & Co., Inc. 5/15/2000
Esketamine  Janssen Pharms 8/2/2017
Eslicarbazepine Sunovion Pharmaceutical, Inc. 7/8/2016
Esmolol Baxter Pharmaceuticals Products, Inc. 9/30/1999
Esomeprazole AstraZeneca Pharmaceuticals, LP 12/31/2001
Eszopiclone Sepracor, Inc. 8/2/2006
Etodolac Wyeth-Ayerst Research 2/3/1999
Etravirine Tibotec, Inc. 4/3/2008
Everolimus Novartis Pharmaceuticals Corporation 4/25/2000
Exenatide Amylin Pharmaceuticals, Inc. 3/29/2006
Ezetimibe MSP Singapore Co., LLC 4/15/2004
Famciclovir Novartis Pharmaceuticals Corporation 9/10/2001
Famotidine Merck & Company, Inc. 8/3/1999
Felodipine Astra Pharmaceuticals, L.P. 12/31/1998
Fenoldopam Elan Pharmaceuticals 4/14/1999
Fentanyl Anesta Corporation 12/23/2003
Fentanyl Janssen Pharmaceuticals 7/15/1999
Ferric Citrate Keryx Biopharmaceuticals, Inc. 5/29/2015
Fesoterodine Pfizer, Inc. 11/14/2011
Fexofenadine Aventis Pharmaceuticals 3/17/2000
Fidaxomicin Merck Sharp & Dohme Corp./Cubist Pharmaceuticals, LLC 5/16/2018
Fingolimod Novartis Pharmaceutical Corporation 3/20/2013
Fluconazole Pfizer Pharmaceuticals Group 12/31/2001
Fludarabine Berlex Laboratories 11/9/2001
Fluocinolone Bausch & Lomb Pharmaceuticals, Inc. 4/12/2001
Fluoxetine Eli Lilly and Company 4/12/1999
Fluticasone Glaxo Wellcome, Inc. 6/25/1999
Fluvastatin Novartis Pharmaceuticals Corporation 12/4/2001
Fluvoxamine Solvay Pharmaceuticals 11/30/1999
Formoterol  Novartis Pharmaceuticals Corporation 12/31/2001
Fosamprenavir GlaxoSmithKline 12/26/2001
Fosaprepitant Merck 2/2/2009
Fosinopril Bristol-Myers Squibb Company 2/3/1999
Fosphenytoin Pfizer, Inc. 12/17/1998
Fospropofol Eisai, Inc. 1/13/2012
Fulvestrant AstraZeneca Pharmaceuticals, LP 10/21/2002
Gabapentin Parke-Davis Pharmaceutical Research 10/9/1998
Gadopentetate Bayer HealthCare Pharmaceuticals, Inc. 1/26/2009
Gatifloxacin Bristol-Myers Squibb Company 5/18/2001
Gatifloxacin Allergan, Inc. 10/4/2001
Gefitinib AstraZeneca, Pharmaceuticals, LP 12/4/2000
Gemcitabine Lilly Research Laboratories 1/9/2001
Gemtuzumab Wyeth-Ayerst Research Laboratories  1/10/2001
Gentamicin Schering Corporation 11/1/1999
Glatiramer TEVA Pharmaceuticals USA 1/3/2000
Glecaprevir/Pibrentasvir AbbVie, Inc. 2/3/2017
Glimepiride Aventis Pharmaceuticals 12/31/2001
Glipizide/Metformin Bristol-Myers Squibb Company 6/18/2002
Glyburide/Metformin Bristol-Myers Squibb Company 1/31/2001
Granisetron  Hoffman La-Roche, Inc. 12/19/2002
Griseofulvin Pedinol Pharmacal, Inc. 9/30/2005
Guanfacine Shire Development, Inc. 10/30/2009
Halobetasol Propionate  Sun Pharmaceutical Industries, Inc.  11/29/2017
Hydrocortisone Atlanta, Inc. 12/12/2003
Hydrocortisone  Bristol-Myers Squibb Company   10/14/2005
Hydromorphone Mallinckrodt, Inc. 3/15/2011
Hydroxyurea Bristol-Myers Squibb Company 3/22/2002
Ibrutinib  Pharmacyclics, LLC 5/18/2018
Ibuprofen McNeil Consumer Products Company 6/8/1998
Ibuprofen Whitehall-Robbins 6/8/1998
Ibuprofen/pseudoephedrine McNeil Consumer Products Company 9/7/1999
Ibuprofen/pseudoephedrine Whitehall-Robbins Healthcare 5/30/2000
Iloperidone Novartis Pharmaceuticals Corporation 5/13/2010
Imatinib Novartis Pharmaceuticals Corporation 9/12/2000
Imiquimod 3M Pharmaceuticals 12/28/2001
Indinavir Merck Research Laboratories 6/25/1999
Insulin aspart [rDNA origin] Novo Nordisk Pharmaceuticals, Inc. 12/14/1999
Insulin glargine Aventis Pharmaceutical, Inc. 12/23/1998
Ipilimumab Bristol-Myers Squibb Company 7/7/2014
Irbesartan Bristol-Myers Squibb Company 12/23/1998
Irinotecan Pharmacia & Upjohn 1/22/2001
Isavuconazonium Astellas Pharma US, Inc. 10/24/2017
Isotretinoin Hoffman-LaRoche, Inc. 6/22/2009
Itraconazole Janssen Pharmaceutica Research 2/9/1999
Ivabradine Corlanor 4/4/2015
Ivacaftor Vertex Pharmaceutical 3/14/2016
Ixabepilone Bristol-Myers Squibb Company 6/22/2007
Ketoconazole Janssen Pharmaceutica Research 4/26/1999
Ketorolac Allergan, Inc. 5/10/2000
Labetalol Schering Corporation 12/23/1998
Lamivudine Glaxo Wellcome, Inc. 11/25/1998
Lamotrigine Glaxo Wellcome, Inc. 12/17/1998
Lansoprazole TAP Holdings, Inc. 8/26/1999
Ledipasvir Gilead Sciences, Inc. 9/2/2016
Leflunomide Hoechst Marion Roussel, Inc. 3/30/1999
Lenalidomide Celgene Corporation 9/13/2014
Levalbuterol Sepracor, Inc. 3/14/2000
Levetiracetam UCB Pharma, Inc. 8/21/2001
Levobetaxolol Alcon Laboratories, Inc. 10/15/1999
Levobunolol Allergan, Inc. 10/15/1999
Levocetirizine UCB, Inc. 2/3/2009
Levofloxacin R.W. Johnson 10/22/1999
Levofloxacin Santen, Inc. 12/20/2001
Levomilnacipran Forest Laboratories, Inc. 9/5/2014
Levonorgestrel/ethinyl estradiol Duramed Research, Inc. 8/14/2005
Linaclotide Forest Laboratories, LLC 3/11/2016
Linezolid Pharmacia & UpJohn 12/22/1999
Liraglutide Novo Nordisk, Inc. 9/13/2012
Lisdexamfetamine Shire 6/3/2014
Lisinopril Zeneca Pharmaceuticals 12/23/1998
Lisinopril Merck & Co., Inc. 12/23/1998
Lithium Roxane 9/26/2003
Lomitapide Aegerion 1/20/2015
Lopinavir/Ritonavir Abbott Laboratories 3/31/1999
Loratadine Schering Corporation 10/15/1998
Lorazepam Wyeth-Ayerst Research 7/5/2002
Lorcaserin Eisai, Inc. 10/24/2017
Losartan Merck Research Laboratories 7/1/1999
Loteprednol Bausch & Lomb, Inc. 4/26/2013
Lovastatin Merck & Co., Inc. 2/3/1999
Lurasidone Sunovion Pharmaceuticals, Inc. 4/20/2012
Macitentan Actelion Clinical Res., Inc. 4/13/2016
Malathion Taro Pharm, USA, Inc. 4/13/2016
Maraviroc Pfizer, Inc. 11/28/2006
Meloxicam Boehringer Ingelheim Pharmaceuticals 11/22/2004
Memantine Forest Research Institute 1/25/2012
Meropenem AstraZeneca 9/10/2004
Mesalamine Procter & Gamble Pharmaceuticals, Inc. 11/30/2001
Mesalamine Shire 5/2/2014
Metformin Bristol-Myers Squibb Company 6/9/1999
Methazolamide Wyeth-Ayerst Laboratories  10/15/1999
Methotrexate Mayne Pharma (USA) Inc. 7/20/2006
Methylphenidate McNeil Consumer & Specialty Pharm. 6/25/2003
Metipranolol Bausch & Lomb 10/15/1999
Metoclopramide Schwarz Pharma, Inc. 7/20/2005
Metoprolol AstraZeneca, Pharmaceuticals, LP 10/19/1999
Micafungin Astellas Pharma US, Inc. 5/23/2007
Miconazole BioAlliance Pharma 3/8/2012
Midazolam Hoffmann-La Roche, Inc. 7/20/1998
Milnacipran Cypress Bioscience, Inc. 2/2/2009
Milrinone Sanofi Synthelabo, Inc. 1/21/2000
Minoxidil Pharmacia & Upjohn Company 11/8/2000
Mirabegron Astellas Pharma Global Development, Inc. 3/18/2016
Mirtazapine Organon, Inc. 4/28/1999
Modafinil Cephalon, Inc. 6/17/2004
Moexipril Schwarz Pharmaceuticals 3/15/1999
Mometasone Schering Corporation 3/17/1999
Mometasone/Formoterol Merck Sharp & Dohme Corp. 7/23/2012
Montelukast Merck & Co., Inc. 3/4/1999
Morphine Elan Drug Delivery 3/28/2003
Morphine Faulding Pharmaceuticals 3/28/2003
Motexafin Pharmacyclics 12/27/2001
Moxifloxacin Alcon Universal, Ltd. 6/26/2000
NAB-paclitaxel Celgene Corporation 10/29/2014
Nabumetone SmithKline Beecham 3/19/1999
Nateglinide Novartis Pharmaceuticals 12/31/2001
Nefazodone Bristol-Myers Squibb Company 4/28/1999
Nelfinavir Agouron Pharmaceuticals, Inc. 3/29/1999
Nevirapine Boehringer Ingelheim Pharmaceuticals 9/11/1998
Nicardipine PDL BioPharma, Inc. 9/18/2007
Nicotine SmithKline Beecham 12/4/1998
Nilotinib Novartis Pharmaceuticals  6/19/2009
Nitric Oxide INO Therapeutics 4/30/2010
Nivolumab Bristol-Myers Squibb Company 9/11/2014
Nizatidine Reliant Pharmaceuticals 6/22/2001
Norfloxacin Merck & Co., Inc. 11/1/1999
Norgestimate/ethinyl estradiol R.W. Johnson Pharmaceutical Research 11/12/2002
Octreotide Novartis Pharmaceuticals Corporation 1/7/2004
Ofloxacin Allergan, Inc. 10/22/1999
Olanzapine Lilly Research Laboratories 11/30/2001
Olmesartan Sankyo Pharma, Inc. 3/6/2001
Olopatadine Alcon Research, Ltd. 7/19/2007
Omeprazole AstraZeneca Pharmaceuticals, LP 7/1/1999
Ondansetron Glaxo Wellcome, Inc. 6/26/2001
Orlistat Hoffman-La Roche, Inc. 8/9/2000
Oseltamivir Hoffman-La Roche, Inc. 3/1/2000
Oxaliplatin Sanofi-Synthelabo, Inc. 12/19/2004
Oxaprozin Searle 2/3/1999
Oxcarbazepine Novartis Pharmaceuticals Corporation 2/28/2000
Oxybutynin Alza Corporation 11/30/2000
Oxybutynin Watson Laboratories, Inc. 5/14/2004
Oxycodone Purdue Pharma L.P. 11/4/1998
Oxymorphone Endo Pharmaceuticals 3/16/2007
Palbociclib Pfizer, Inc. 7/3/2018
Paliperidone J&J Pharmaceuticals 11/2/2006
Palonosetron Helsinn Healthcare SA 7/23/2010
Pantoprazole Wyeth-Ayerst Laboratories 12/31/2001
Paricalcitol Abbott Laboratories 2/22/2001
Paroxetine SmithKline Beecham Pharmaceuticals 4/28/1999
Peginesatide Affymax, Inc. 1/4/2013
Pegvisomant Pharmacia & Upjohn Co. 5/23/2003
Pemetrexed Eli Lilly & Company 10/5/2001
Perampanel  NEW Eisai, Inc. 3/20/2018
Pemirolast Santen, Inc. 2/18/1999
Pimavanserin Acadia Pharms, Inc. 12/13/2018
Pimecrolimus Novartis Pharmaceutical Corporation 9/27/1999
Pioglitazone  Takeda Pharmaceuticals, Inc. 4/3/2002
Pitavastatin Kowa Research Institute, Inc. 11/2/2016
Plerixafor Genzyme 6/29/2015
Polyethylene Glycol 3350 Braintree Laboratories, Inc. 12/27/2001
Pomalidomide Celgene Corporation 11/20/2015
Posaconazole Schering Corporation 2/28/2008
Pramipexole Boehringer-Ingelheim 2/13/2009
Prasugrel Eli Lilly & Co. 12/19/2012
Pravastatin Bristol-Myers Squibb 8/4/1999
Pregabalin Pfizer Global 6/8/2005
Propofol Zeneca Pharmaceuticals 4/2/1999
Quetiapine AstraZeneca Pharmaceuticals, LP 2/11/2003
Quinapril Parke-Davis Pharmaceutical Research 12/23/1998
Rabeprazole Eisai, Inc. 12/31/2001
Raltegravir Merck & Co., Inc. 8/18/2006
Ramelteon Takeda Global Research 6/2/2011
Ramipril King Pharmaceuticals 12/19/2001
Ramucirumab NEW Eli Lilly and Company  12/16/2017
Ranitidine GlaxoWellcome, Inc.  8/26/1998
Remifentanil Glaxo Wellcome, Inc. 12/17/1998
Repaglinide Novo Nordisk 2/1/2000
Ribavirin/Interferon alfa-2B, recombinant Schering-Plough Research Institute 1/25/1999
Rifampin Aventis Pharmaceuticals, Inc. 9/30/2003
Rifapentine Hoechst Marion Roussel, Inc. 6/19/1998
Rifaximin Salix Pharmaceuticals, Inc. 4/15/2003
Rilpivirine Janssen Prods 7/30/2008
Risedronate Procter & Gamble Pharmaceuticals 4/19/2002
Risperidone Janssen Research Foundation 11/25/2002
Ritonavir Abbott Laboratories 4/16/1999
Rivaroxaban Janssen Research & Development, LLC 6/8/2017
Rizatriptan Merck Research Laboratories 3/6/2009
Rocuronium Organon, Inc. 12/31/2001
Rofecoxib Merck & Co., Inc. 5/7/2001
Ropivacaine AstraZeneca Pharmaceuticals, LP 3/2/2000
Rosiglitazone SmithKline Beecham Pharmaceuticals 2/1/2000
Rosiglitazone S.B. Pharmco Puerto Rico, Inc. 12/15/2003
Rosuvastatin AstraZeneca Pharmaceuticals, LP 3/7/2006
Rufinamide Eisai, Inc. 6/21/2000
Ruxolitinib Jakafinda 12/11/2015
Sacubitril/Valsartan Novartis Pharmaceuticals Corp. 3/2/2017
Salmeterol Glaxo Wellcome, Inc. 5/20/1999
Sapropterin BioMarin Pharmaceutical, Inc. 1/14/2008
Saquinavir Hoffman-La Roche Inc. 4/9/1999
Sertraline Pfizer Pharmaceuticals 4/28/1999
Sevelamer GelTex Pharmaceuticals, Inc. 1/15/2002
Sevoflurane Abbott Laboratories 3/2/2000
Sibutramine Knoll Pharmaceuticals 6/1/1999
Sildenafil Pfizer, Inc. 12/17/2001
Simvastatin Merck & Co., Inc. 8/31/1999
Sirolimus Wyeth-Ayerst Research 9/15/1999
Sitagliptin Merck Sharp & Dohme Corp. 11/16/2012
Sodium ferric gluconate complex Watson Laboratories, Inc. 8/9/2002
Sodium Nitroprusside  Abbott Laboratories 7/8/2002
Sodium oxybate Jazz Pharmaceuticals 3/10/2014
Sofosbuvir Gilead Sciences, Inc. 9/2/2016
Solifenacin Astellas Pharma Global 7/27/2012
Somatropin [rDNA origin] Serono Laboratories 6/28/2000
Sotalol Berlex Laboratories, Inc. 1/15/1999
Stavudine Bristol-Myers Squibb 8/20/1999
Sugammadex Organon USA, Inc. 10/28/2016
Sumatriptan Glaxo Wellcome, Inc. 4/24/2014
Sumatriptan/naproxen Pozen, Inc. 6/29/2007
Sunitinib C.P. Pharmaceuticals Intl c/o Pfizer, Inc. 10/23/2006
Tacrolimus R-Tech Ueno (USA), Inc. 4/19/2000
Tadalafil Eli Lilly and Company 11/6/2006
Tamoxifen AstraZeneca Pharmaceuticals 4/5/2000
Tamsulosin Boehringer Ingelheim Pharmaceuticals 1/10/2006
Tapentadol Janssen Research & Development, LLC 7/8/2013
Tavaborole Anacor Pharmaceuticals, Inc. 4/17/2015
Tbo-filgrastin Teva Branded Pharmaceutical Products R&D, Inc. 9/21/2017
Technetium Tc99m Sestamibi Bristol-Myers Squibb Medical Imaging 12/17/2004
Teduglutide NPS Pharmaceuticals, Inc. 6/12/2015
Telaprevir Vertex Pharmaceuticals, Inc. 10/7/2011
Telbivudine Idenix Pharmaceuticals Inc. 12/1/2006
Temozolomide Schering Corporation 1/9/2001
Temsirolimus Wyeth-Ayerst Research Laboratories  1/12/2001
Tenofovir Gilead Sciences, Inc. 12/21/2001
Terbinafine Novartis Pharmaceuticals Corporation 2/28/2001
Teriflunamide Sanofi-Aventis U.S., Inc. 3/7/2013
Testosterone Unimed Pharmaceuticals, Inc. 6/21/2002
Tetrabenazine Biovail Technologies, Ltd. 7/30/2010
Timolol Merck Research Laboratories 7/6/1999
Timolol Falcon Pharmaceuticals 10/15/1999
Timolol Santen Incorporated 10/15/1999
Tiotropium Bromide Boehringer Ingelheim 2/12/2016
Tipranavir Boehringer Ingelheim Pharmaceuticals 1/22/2003
Tizanidine Acorda Therapeutics, Inc. 12/20/2012
Tobramycin Alcon Laboratories 10/22/1999
Tobramycin Falcon Pharmaceuticals 10/22/1999
Tocilizumab Hoffmann-LaRoche, Inc. 11/15/2012
Tofacitinib P.F. Prism CV 8/12/2015
Tolterodine Pharmacia & Upjohn Company 1/23/2001
Tolvaptan Otsuka Pharmaceutical Company, Ltd. 6/15/2011
Topiramate The R.W. Johnson 7/9/2004
Topotecan SmithKline Beecham 5/16/2000
Tramadol R.W. Johnson 3/30/1999
Trametinib Novartis Pharmaceuticals Corporation 3/1/2016
Valacyclovir GlaxoSmithKline 8/2/2001
Valganciclovir Roche Pharmaceuticals 6/20/2001
Valsartan Novartis Pharmaceuticals 12/19/2000
Varenicline Pfizer, Inc. 6/12/2007
Velpatasvir(VEL) Gilead Sciences, Inc. 9/2/2016
Venetoclax  NEW AbbVie, Inc. 7/5/2018
Venlafaxine Wyeth-Ayerst Laboratories  4/28/1999
Verapamil Elan Pharmaceutical Research Corp. 2/3/1999
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