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Blog & Resources Camargo Blog October 27th, 2009

Did FDA Make a Mistake? Prodrug Emend Exclusivity Reconsidered

It 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 just that. See item H of Docket No. FDA-2009-N-0184 public docket is excerpted as follows:

vyvance-response1

It appears that the FDA will now reexamine the NCE status of Emend (fosaprepitant dimeglumine) for Injection. This will be interesting to follow in future postings to this blog.



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