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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.
| Drug |
Sponsor |
Determination Date |
Written Request and Related Documents |
| Eplerenone |
Pfizer |
10/24/2007 |
|
| Anastrozole |
AstraZeneca |
11/14/2007 |
|
| Aripiprazole |
Otsuka |
11/14/2007 |
|
| Valproate |
Abbott |
12/14/2007 |
|
| Zoledronic acid |
Novartis |
12/21/2007 |
|
| Technetium Tc99 sestamibi |
BMS |
1/11/2008 |
|
| Ezetimibe |
Schering Corporation |
2/14/2008 |
|
| Valacyclovir |
GlaxoSmithKline |
2/28/2008 |
|
| Lopinavir/ritonavir |
Abbott Laboratories |
3/7/2008 |
|
| Tipranavir |
Boehringer Ingelheim Pharmaceuticals, Inc. |
3/7/2008 |
|
| Rocuronium |
Organon, Inc. |
4/3/2008 |
|
| Caspofungin |
Merck & Co., Inc. |
4/15/2008 |
|
Levetiracetam |
UCB, Inc. |
6/3/2008 |
|
Lansoprazole  |
Tap Pharmaceutical Products, Inc. |
7/15/2008 |
|
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Date created: December 31, 2007; Last updated: July 24, 2008 |
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