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  1. Development Resources

List of Determinations Including Written Request

Pediatric Exclusivity Determinations Made under Section 505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.  In addition, it provides a link to a copy of the Written Request and any amendments.

NOTE: Only applications held by the identified sponsor were granted pediatric exclusivity. We will update this page each time a determination is made.

The administrative amendments issued during the summer of 2002 and spring of 2004, which cover the passage of the Best Pharmaceuticals for Children Act on January 4, 2002, and the requirement for submitted reports to include more specific information on racial and ethnic minorities, respectively, may not be listed below for original Written Requests that predate their release (e.g., bicalutamide).

N=132

Drug Sponsor Determination Date Written Request and Related Documents
Abatacept   BMS 2/14/2017
 
Acetaminophen Mallinckrodt 7/11/2016
Albuterol GlaxoSmithKline 8/27/2008
Alfuzosin Sanofi Aventis 9/7/2010
Aliskiren Noden Pharma DAC 10/3/2017
Almotriptan Johnson & Johnson Pharmaceutical Research & Development /1/13/2009
Amphetamine Shire 8/18/2019
Anastrozole AstraZeneca 11/14/2007
Aripiprazole Otsuka 11/14/2007
Asenapine Forest Labs 3/3/2015
Atazanavir  BMS 6/23/2015
Atezolizumab Genentech 9/22/2020
Azelastine/Fluticasone and Azelastine Meda Pharmaceuticals 3/23/2015
Bendamustine Cephalon 5/24/2012
Bicalutamide AstraZeneca 9/19/2008
Bivalirudin The Medicines Company 6/17/2009
Bortezomib Millennium Pharmaceuticals 8/14/2015
Budesonide/Formoterol AstraZeneca
 
1/25/2017
 
Cabazitaxel Sanofi Aventis
 
5/18/2017
Calcipotriene/Betamethasone Leo Pharma 7/15/2019
Candesartan AstraZeneca Pharmaceuticals LP 7/20/2009
Capecitabine Hoffman-La Roche, Inc. 8/28/2013

 

Caspofungin Merck & Co., Inc. 4/15/2008
Cetirizine Nicox Ophthalmics  8/29/16 
Clopidogrel Sanofi Aventis 1/20/2011
Colesevelam Daiichi Sankyo Pharma 2/17/2009
Crisaborole Pfizer 2/21/2020
Cysteamine Horizon 12/12/2017
Dabigatran Boehringer Ingelheim Pharmaceuticals, Inc. 2/12/2021
Darunavir Tibotec 6/7/2011
Deutetrabenazine  Teva Branded Pharmaceutical Products 5/5/2021
Dexmedetomidine Hospira 3/12/2013
Difluprednate Alcon 3/21/2013
Docetaxel Sanofi Aventis 3/17/2010
Duloxetine Eli Lilly 7/2/2012
Efavirenz BMS 1/29/2013
Eltrombopag  Novartis 8/14/2015
Entecavir BMS 12/5/2013
Eplerenone Pfizer 10/24/2007
Erlotinib OSI Pharmaceuticals 3/18/2015
Esomeprazole AstraZeneca LP 5/1/2009
Eszopiclone Sunovion 6/29/2012
Etravirine  Janssen 6/21/2018
Everolimus Novartis 7/10/2012
Exenatide AstraZeneca 4/1/2021
Ezetimibe Schering Corporation 2/14/2008
Famciclovir Novartis 9/21/2009
Fidaxomicin Cubist 12/13/2019
Finafloxacin Alcon 8/25/2014

Fingolimod  

 

Novartis 4/16/2018
 
Fosamprenavir ViiV Healthcare 1/10/2012
Fosaprepitant Merck  3/23/2018
Fulvestrant AstraZeneca 2/1/2011
Gatifloxacin Allergan 5/19/2009
Glecaprevir/Pibrentasvir AbbVie, Inc. 5/18/2021
Guanfacine Shire 10/17/2014
Halobetasol NEW
Mayne Pharma LLC 5/21/2021
Ipilimumab BMS 7/20/17
Ixabepilone  BMS 4/5/2011
Ivabradine  
 
Amgen 3/30/2019
Lansoprazole Tap Pharmaceutical Products, Inc. 7/15/2008
Levetiracetam UCB, Inc. 6/3/2008
Levocetirizine UCB, Inc. 8/25/2009
Liraglutide  Novo Nordisk 5/1/2019
Loteprednol/Tobramycin Bausch & Lomb 12/28/2010
Lopinavir/Ritonavir Abbott Laboratories 3/7/2008
Lurasidone Sunovion 12/20/2016
Maraviroc ViiV Healthcare Co 7/29/2020
Memantine Forest Labs 6/16/2014
Methylphenidate
 
Rhodes Pharmaceuticals 3/15/2019
Micafungin Astellas 11/14/2019
Mirabegron Astellas Pharma Global Development, Inc. 3/1/2021
Mometasone/formoterol Merck 6/24/2019
Nilotinib  Novartis 3/20/2018
Nitric Oxide INO Therapeutics 11/2/2010
Olmesartan Daiichi Sankyo 10/7/2009
Olopatadine Alcon Research, Ltd. 8/12/2009
Olopatadine Alcon Research, Ltd. 12/16/2014
Paclitaxel Abraxis 11/8/2019
Paliperidone Ortho-McNeil-Janssen Pharmaceuticals, Inc. 1/5/2011
Palonosetron Helsinn 4/10/2014
Pantoprazole Wyeth Pharmaceuticals, Inc. 2/17/2009
Pemetrexed Eli Lilly 12/3/2010
Phenylephrine/Ketorolac Omeros 12/6/2017
Pitavastatin   
 
Kowa Research Institute] 3/30/2019
Pomalidomide Celgene Corporation 10/16/2020
Prasugrel   Eli Lilly 5/23/16
Quetiapine AstraZeneca Pharmaceuticals LP 1/23/2009
Rabeprazole Eisai 12/4/2012
Raltegravir Merck 8/14/2017
Risedronate Procter & Gamble Pharmaceuticals, Inc. 4/24/2009
Rizatriptan Merck 9/20/2011
Rocuronium Organon, Inc. 4/3/2008
Rosuvastatin AstraZeneca Pharmaceuticals LP 7/7/2009
Rufinamide Eisai 1/13/2015
Sacubitril/Valsartan
Novartis
9/26/2019
Sapropterin BioMarin 3/13/2014
Saquinavir Hoffman-La Roche, Inc. 10/26/2010
Sildenafil Pfizer 2/9/2012
Sitagliptin Merck Sharp & Dohme Corp. 10/30/2020
Sofosbuvir  Gilead Sciences, Inc. 7/23/2019
Sofosbuvir/Ledipasvir  Gilead Sciences, Inc. 7/23/2019
Sofosbuvir/Velpatasvir
 
Gilead Sciences, Inc. 5/13/2021
Solifenacin Astellas 7/20/2017
Sumatriptan/Naproxen GlaxoSmithKline/Pernix 4/16/2015
Tadalafil   Eli Lilly  11/16/2017 
Tamsulosin Boehringer Ingelheim 9/17/2009
Tavaborole Anacor 7/18/2018
Tbo-filgrastim  Sicor
 
7/18/2018
Technetium Tc99 sestamibi BMS 1/11/2008
Teduglutide  Shire - NPS Pharmaceuticals 
 
3/7/2019
Temsirolimus Pfizer 2/28/2012
Tenofovir Gilead Sciences, Inc. 9/6/2011
Tenofovir
 
Gilead Sciences, Inc. 11/15/2018  
 
Teriflunomide Sanofi Aventis 3/31/2021
Tiotropium Boehringer Ingelheim Pharmaceuticals, Inc. 12/14/16
Tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. 3/7/2008
Tocilizumab Genentech/Hoffmann-La Roche
 
7/18/2018
Topiramate Ortho-McNeil-Janssen Pharmaceuticals, Inc. 7/24/2008
Trabectedin Janssen 6/12/2018
Valacyclovir GlaxoSmithKline 2/28/2008
Valganciclovir Hoffman-La Roche Inc. 7/24/2008
Valproate   Abbott 12/14/2007
Varenicline
 
Pfizer 11/15/2018
Vigabatrin Lundbeck 10/3/2013

Vilazodone

Allergan 1/21/2020
Zoledronic acid Novartis 12/21/2007

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