United States DC Circuit
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