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=171
| Drug | Sponsor | Determination Date | Written Request and Related Documents |
|---|---|---|---|
| Abacavir/ dolutegravir/ lamivudine | ViiV Healthcare Company | 6/7/2023 |
|
| Abatacept | BMS | 2/14/2017 |
|
| Acetaminophen | Mallinckrodt | 7/11/2016 |
|
| Afatinib | Boehringer Ingelheim Pharmaceuticals, Inc. | 3/8/2022 |
|
| Aflibercept | Regeneron Pharmaceuticals | 10/18/2022 |
|
| 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 |
|
| Apremilast | Amgen Inc. | 4/22/2024 |
|
| Aripiprazole | Otsuka | 11/14/2007 |
|
| Asenapine | Forest Labs | 3/3/2015 |
|
| Atazanavir | BMS | 6/23/2015 |
|
| Atezolizumab | Genentech | 9/22/2020 |
|
| Axitinib NEW | Pfizer, Inc. | 7/2/2024 |
|
| Azelastine/Fluticasone and Azelastine | Meda Pharmaceuticals | 3/23/2015 |
|
| Bendamustine | Cephalon | 5/24/2012 |
|
| Bezlotoxumab | Merck Sharpe and Dohme | 5/12/2023 |
|
| Bicalutamide | AstraZeneca | 9/19/2008 |
|
| Bivalirudin | The Medicines Company | 6/17/2009 |
|
| Blinatumomab | Amgen | 6/13/2023 |
|
| Bosutinib | PF Prism, C.V. | 9/7/ 2023 |
|
| Bortezomib | Millennium Pharmaceuticals | 8/14/2015 |
|
| Brentuximab vedotin | Seagen, Inc. | 11/18/2022 |
|
| Brexpiprazole | Otsuka Pharmaceutical Development & Commercialization | 5/2/2024 |
|
| 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 |
|
| Cobimetinib | Genentech, Inc. | 7/19/2022 |
|
| 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 |
|
| Dabrafenib | Novartis | 2/9/2023 |
|
| Dapagliflozin | AstraZeneca AB | 5/30/2024 |
|
| 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 |
|
| Dulaglutide | Eli Lilly and Company | October 4, 2022 |
|
| Duloxetine | Eli Lilly | 7/2/2012 |
|
| Efavirenz | BMS | 1/29/2013 |
|
| Eltrombopag | Novartis | 8/14/2015 |
|
| Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide | Gilead Sciences, Incorporated | 9/13/2021 |
|
| Empagliflozin/Empagliflozin and Metformin hydrochloride | Boehringer Ingelheim Pharmaceuticals | 6/9/2023 |
|
| Entecavir | BMS | 12/5/2013 |
|
| Eplerenone | Pfizer | 10/24/2007 |
|
| Eribulin Mesylate | Eisai, Inc. | 8/9/2022 |
|
| 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 |
|
|
Fenfluramine hydrochloride |
Zogenix, Inc | 3/23/2022 |
|
| Ferric Oxyhydroxide | Vifor Fresenius Medical Care Renal Pharma France | 6/1/2021 |
|
| Fesoterodine | Pfizer | 6/3/2021 |
|
| Fidaxomicin | Cubist | 12/13/2019 |
|
| Finafloxacin | Alcon | 8/25/2014 |
|
|
Fingolimod
|
Novartis | 4/16/2018 |
|
| Fluticasone & Fluticasone/Salmeterol | Teva Pharmaceutical Industries Ltd. | 6/10/2021 |
|
| Fluticasone furoate vilanterol trifenatate | GlaxoSmithKline | 4/26/2023 |
|
| 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
|
Mayne Pharma LLC | 5/21/2021 |
|
| Ibrutinib | Pharmacyclics | 8/8/2022 |
|
| Ipilimumab | BMS | 7/20/17 |
|
| Isavuconazonium sulfate | Astellas Pharma US Inc. | 11/29/2023 |
|
| Ixabepilone | BMS | 4/5/2011 |
|
| Ivabradine |
Amgen | 3/30/2019 |
|
| Lanadelumab | Takeda Pharmaceuticals U.S.A., Inc. | 12/20/2022 |
|
| Lansoprazole | Tap Pharmaceutical Products, Inc. | 7/15/2008 |
|
| Lenvatinib Mesylate | Eisai Inc. | 4/1/2024 |
|
| Levetiracetam | UCB, Inc. | 6/3/2008 |
|
| Levocetirizine | UCB, Inc. | 8/25/2009 |
|
| Linagliptin/Linagliptin and metformin hydrochloride | Boehringer Ingelheim Pharmaceuticals | 6/9/2023 |
|
| Liraglutide | Novo Nordisk | 5/1/2019 |
|
| Lisdexamfetamine | Takeda Pharmaceuticals USA, Inc. |
7/27/2021 |
|
| Loteprednol/Tobramycin | Bausch & Lomb | 12/28/2010 |
|
| Lopinavir/Ritonavir | Abbott Laboratories | 3/7/2008 |
|
| Lurasidone | Sunovion | 12/20/2016 |
|
| Lutetium Lu 177 dotatate | Advanced Accelerator Applications | 4/19/2024 |
|
| 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 |
|
| Nintedanib | Boehringer Ingelheim Pharmaceuticals | 10/6/2023 |
|
| Nitric Oxide | INO Therapeutics | 11/2/2010 |
|
| Nivolumab |
2/2/2023 |
|
|
| 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 |
|
| Remdesivir | Gilead Sciences, Inc. | January 23, 2024 |
|
| Rilpivirine | Janssen Products, LP. | 1/18/2024 |
|
| Risedronate | Procter & Gamble Pharmaceuticals, Inc. | 4/24/2009 |
|
| Rivaroxaban | Janssen Pharmaceuticals, Inc. | 11/23/2021 |
|
| Rizatriptan | Merck | 9/20/2011 |
|
| Rocuronium | Organon, Inc. | 4/3/2008 |
|
| Rosuvastatin | AstraZeneca Pharmaceuticals LP | 7/7/2009 |
|
| Rufinamide | Eisai | 1/13/2015 |
|
| Ruxolitinib | Incyte Corporation | 12/1/2022 |
|
| 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 |
|
| Tapentadol | Collegium Pharmaceutical Inc. | June 11, 2024 |
|
| 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 |
|
| Ticagrelor | AstraZeneca | 4/8/2022 |
|
| 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 |
|
| Trametinib | Novartis | 2/9/2023 |
|
| 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 |
|
| Vortioxetine | Takeda Pharmaceuticals USA Inc. | 8/21/2023 |
|
| Zoledronic acid | Novartis | 12/21/2007 |
|
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