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Actavis Elizabeth LLC v. FDA, No. 10-5066

By FindLaw Staff on November 09, 2010 10:59 AM

Petition for Review of FDA Order

In Actavis Elizabeth LLC v. FDA, No. 10-5066, 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, the court affirmed summary judgment for defendants 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.

As the court wrote:  "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."

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