Drugs
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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.
N=49
| Drug | Sponsor | Determination Date | Written Request and Related Documents |
|---|---|---|---|
| Albuterol | GlaxoSmithKline | 8/27/2008 |
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| Alfuzosin | Sanofi Aventis | 9/7/2010 |
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| Almotriptan | Johnson & Johnson Pharmaceutical Research & Development | 1/13/2009 |
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| Anastrozole | AstraZeneca | 11/14/2007 |
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| Aripiprazole | Otsuka | 11/14/2007 |
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| Bicalutamide | AstraZeneca | 9/19/2008 |
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| Bivalirudin | The Medicines Company | 6/17/2009 |
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| Candesartan | AstraZeneca Pharmaceuticals LP | 7/20/2009 |
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| Caspofungin | Merck & Co., Inc. | 4/15/2008 |
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| Clopidogrel | Sanofi Aventis | 1/20/2011 |
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| Colesevelam | Daiichi Sankyo Pharma | 2/17/2009 |
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| Darunavir | Tibotec | 6/7/2011 |
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| Docetaxel | Sanofi Aventis | 3/17/2010 |
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| Eplerenone | Pfizer | 10/24/2007 |
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| Esomeprazole | AstraZeneca LP | 5/1/2009 |
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| Ezetimibe | Schering Corporation | 2/14/2008 |
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| Famciclovir | Novartis | 9/21/2009 |
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| Fosamprenavir | ViiV Healthcare | 1/10/2012 |
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| Fulvestrant | AstraZeneca | 2/1/2011 |
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| Gatifloxacin | Allergan | 5/19/2009 |
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| Ixabepilone | BMS | 4/5/2011 |
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| Lansoprazole | Tap Pharmaceutical Products, Inc. | 7/15/2008 |
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| Levetiracetam | UCB, Inc. | 6/3/2008 |
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| Levocetirizine | UCB, Inc. | 8/25/2009 |
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| Loteprednol/Tobramycin | Bausch & Lomb | 12/28/2010 |
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| Lopinavir/Ritonavir | Abbott Laboratories | 3/7/2008 |
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| Nitric Oxide | INO Therapeutics | 11/2/2010 |
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| Olmesartan | Daiichi Sankyo | 10/7/2009 |
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| Olopatadine | Alcon Research, Ltd. | 8/12/2009 |
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| Paliperidone | Ortho-McNeil-Janssen Pharmaceuticals, Inc. | 1/5/2011 |
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| Pantoprazole | Wyeth Pharmaceuticals, Inc. | 2/17/2009 |
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| Pemetrexed | Eli Lilly | 12/3/2010 |
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| Quetiapine | AstraZeneca Pharmaceuticals LP | 1/23/2009 |
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| Risedronate | Procter & Gamble Pharmaceuticals, Inc. | 4/24/2009 |
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| Rizatriptan | Merck | 9/20/2011 |
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| Rocuronium | Organon, Inc. | 4/3/2008 |
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| Rosuvastatin | AstraZeneca Pharmaceuticals LP | 7/7/2009 |
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| Saquinavir | Hoffman-La Roche, Inc. | 10/26/2010 |
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| Sildenafil | Pfizer | 2/9/2012 |
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| Tamsulosin | Boehringer Ingelheim | 9/17/2009 |
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| Technetium Tc99 sestamibi | BMS | 1/11/2008 |
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Temsirolimus  | Pfizer | 2/28/2012 |
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| Tenofovir | Gilead Sciences, Inc. | 9/6/2011 |
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| Tipranavir | Boehringer Ingelheim Pharmaceuticals, Inc. | 3/7/2008 |
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| Topiramate | Ortho-McNeil-Janssen Pharmaceuticals, Inc. | 7/24/2008 |
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| Valacyclovir | GlaxoSmithKline | 2/28/2008 |
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| Valganciclovir | Hoffman-La Roche Inc. | 7/24/2008 |
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| Valproate | Abbott | 12/14/2007 |
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| Zoledronic acid | Novartis | 12/21/2007 |
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* Persons with disabilities having problems accessing the PDF files may call (301) 796-3634 for assistance.
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