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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.

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.

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


UCB, Inc. 6/3/2008


Tap Pharmaceutical Products, Inc. 7/15/2008


Ortho-McNeil-Janssen Pharmaceuticals, Inc. 7/24/2008


Hoffman-La Roche Inc. 7/24/2008

Albuterol New!!

GlaxoSmithKline 8/27/2008

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Date created: December 31, 2007; Last updated: September 4, 2008

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