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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=33
| Drug | Sponsor | Determination Date | Written Request and Related Documents |
|---|---|---|---|
| Albuterol | GlaxoSmithKline | 8/27/2008 |
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| Almotriptan | Johnson & Johnson Pharmaceutical Research & Development | 1/13/2009 |
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| Anastrozole | AstraZeneca | 11/14/2007 | |
| 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 | |
| Colesevelam | Daiichi Sankyo Pharma | 2/17/2009 |
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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 | |
| Famciclovir | Novartis | 9/21/2009 |
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| Gatifloxacin | Allergan | 5/19/2009 |
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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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| Lopinavir/ritonavir | Abbott Laboratories | 3/7/2008 |
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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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| Pantoprazole | Wyeth Pharmaceuticals, Inc. | 2/17/2009 |
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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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| Rocuronium | Organon, Inc. | 4/3/2008 | |
| Rosuvastatin | AstraZeneca Pharmaceuticals LP | 7/7/2009 |
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| Tamsulosin | Boehringer Ingelheim | 9/17/2009 |
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| Technetium Tc99 sestamibi | BMS | 1/11/2008 | |
| 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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