Actavis Loses to FDA|in ADHD Drug Ruling

     (CN) – A generic drug maker lost its challenge of a Food and Drug Administration decision granting a five-year period of market exclusivity to the manufacturer of Vyvanse, a drug for attention deficit hyperactivity disorder.




     Actavis Elizabeth LLC claimed that it should be able to sell its generic version of the ADHD drug, because Shire Pharmaceuticals’ Vyvanse was not a “new chemical entity” under the Federal Food, Drug and Cosmetic Act.
     U.S. District Judge Rosemary Collyer in Washington, D.C., deferred to the FDA’s judgment in denying Actavis’ motion for summary judgment.
     The FDA had approved Shire’s drug application for lisdexamfetamine dimesylate, or LDX, in February 2007, giving the company five years of market exclusivity based on the drug’s new chemical entity.
     Last January, Actavis asked the FDA for permission to sell a generic version, but the agency turned it down.
     The FDA grants market exclusivity to drugs that contain no active ingredients that have been previously approved. It defines an active ingredient as a molecule or ion, and Actavis argued that the active ingredient has to refer to the molecule that actually provides therapeutic effect.
     Judge Collyer deferred to the FDA’s determination, ruling that Shire can retain market exclusivity until February 2012.

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