United States DC Circuit

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Actavis Elizabeth LLC v. FDA, 10-5066

In a petition for review of the FDA's order that Vyvanse, a name-brand drug for the treatment of attention deficit hyperactivity disorder (ADHD), was entitled to five years of marketing exclusivity, summary judgment for defendant is affirmed where: 1) since lisdexamfetamine contained an amide bond, the FDA properly treated it as an "active moiety" of its own; and 2) given the complexity of the statutory regime, the court deferred to the agency's interpretation.

Appellate Information

  • Decided 11/09/2010
  • Published 11/09/2010

Judges

  • Raymond Randolph

Court

  • United States DC Circuit

Counsel

  • For Appellant:
  • Chad A. Landmon, Andrew E. Clark