Legal Opinion
Actavis Elizabeth LLC v. United States Food & Drug Administration
Court of Appeals for the D.C. Circuit
Decided November 9, 2010No. 10-5066PublishedCited by 13 opinions
1Opinion of the Court
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 Aetavis 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, Aetavis submitted an application for lisdexamfetamine dimesylate, a generic version of the same drug. The FDA returned Aetavis’ application. It did so because it had previously determined that Vyvanse was entitied to five years of…
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