ACTAVIS ELIZABETH LLC v. U.S. FOOD & DRUG ADMIN.

Civil Action No. 09-362(RMC).

689 F.Supp.2d 174 (2010)

ACTAVIS ELIZABETH LLC, Plaintiff, v. UNITED STATES FOOD & DRUG ADMINISTRATION, et al., Defendants.

United States District Court, District of Columbia.

March 4, 2010.


Attorney(s) appearing for the Case

James David Veltrop, Chad A. Landmon, Jo Anne M. Kokoski, Axinn, Veltrop & Harkrider, L.L.P., Hartford, CT, Robert B. Greenbaum, Axinn Veltrop & Harkrider LLP, Washington, DC, for Plaintiff.

Andrew E. Clark, US Department of Justice, Office of Consumer Litigation, Washington, DC, for Defendants.

George F. Pappas, Peter O. Safir, Emily Johnson Henn, Bradley K. Ervin, Covington & Burling, LLP, Washington, DC, for Shire Pharmaceuticals Inc.


MEMORANDUM OPINION

ROSEMARY M. COLLYER, District Judge.

Actavis Elizabeth LLC seeks judicial review of a decision of the United States Food and Drug Administration awarding five years of market exclusivity to Intervenor-Defendant Shire Pharmaceuticals Inc. for the manufacture of lisdexamfetamine dimesylate ("LDX"), currently marketed by Shire's subsidiary in the United States under the trade name Vyvanse®. Actavis disagrees with the agency's conclusion...

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