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).
Find the Pediatric Exclusivity Determinations in the FDA Archive
Go to Pediatric Exclusivity Determinations Including Written Requests
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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