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

No. 10-5066.

625 F.3d 760 (2010)

ACTAVIS ELIZABETH LLC, Appellant v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided November 9, 2010.

Attorney(s) appearing for the Case

Chad A. Landmon argued the cause for appellant. With him on the briefs was Robert B. Greenbaum.

Andrew E. Clark , Senior Litigation Counsel, U.S. Department of Justice, argued the cause for federal appellees. With him on the brief were Eugene M. Thirolf Jr. , Director, and Eric M. Blumberg , Deputy Chief Counsel, U.S. Department of Health & Human Services. R. Craig Lawrence , Assistant U.S. Attorney, entered an appearance.

George F. Pappas , Peter O. Safir , and Emily J. Henn were on the brief for appellee Shire Pharmaceuticals, Inc.

Opinion for the Court filed by Senior Circuit Judge RANDOLPH.

RANDOLPH, Senior Circuit Judge:

This is an appeal from the order of the district court granting summary judgment against Actavis Elizabeth LLC. In 2007, the Food and Drug Administration approved Vyvanse, a name-brand drug for the treatment of attention deficit hyperactivity disorder. Two years later, Actavis submitted an application for lisdexamfetamine dimesylate, a generic version of the same drug. The FDA returned Actavis' application. It did so because it had...

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