Did FDA Make a Mistake? Prodrug Emend Exclusivity Reconsidered

Published On: October 27, 2009

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:

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.