Intellipharmaceutics International Inc. (IPCI)

[InTheTrenches]

The PDUFA legislation mandated that the FDA must respond to an NDA within 60 days. Before PDUFA, there was a backlog of NDAs at times that caused long delays (> 60 days) of NDA acceptance (sound familiar??).

The FDA usually takes close to the full 60 days to accept/reject the NDA.


As an example, Relypsa recently went through an NDA for Veltassa:

- October 22, 2014: Submitted NDA

- December 15, 2014: NDA accepted by the FDA

- January 5, 2015: ("day-74 letter") Assigned a PDUFA date of October 21, 2015 and FDA "further indicated that it does not currently plan to convene an Advisory Committee for advice on the company's NDA.". This was a standard 10-month review.

- October 21, 2015: FDA approves Veltassa