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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, October 27th, 2009.
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Did FDA make a mistake? Prodrug Emend exclusivity reconsidered
Published October 27th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsIt is important to give the FDA credit for admitting mistakes. Yesterday’s posting in this blog concerned Vyvance’s NCE and 5 year exclusivity status.
The thorough response by the FDA to the Actavis request for reconsideration of the new chemical entity (NCE) 5 year exclusivity granted to Vyvanse (lisdexamfetamine dimesylate) Capsules, the prodrug of dexamphetamine, included [...]