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	Written Request Amendment_1 Amendment_2 Amendment_3 Memo to File
Anastrozole	AstraZeneca	11/14/2007	Written Request - Amendment 4
Aripiprazole	Otsuka	11/14/2007	Written Request
Valproate	Abbott	12/14/2007	Written Request
Zoledronic acid	Novartis	12/21/2007	Written Request
Technetium Tc99 sestamibi	BMS	1/11/2008	Written Request- Amendment 2
Ezetimibe	Schering Corporation	2/14/2008	Written Request - Amendment 1
Valacyclovir	GlaxoSmithKline	2/28/2008	Written Request Amendment 1
Lopinavir/ritonavir	Abbott Laboratories	3/7/2008	Written Request Amendment 1 Amendment 2 Amendment_3 Amendment_4 Amendment 5 Amendment 6
Tipranavir	Boehringer Ingelheim Pharmaceuticals, Inc.	3/7/2008	Written Request
Rocuronium	Organon, Inc.	4/3/2008	Written Request - Amendment 6

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Date created: December 31, 2007; Last Updated: May 2, 2008

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