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Re: Ajax133 post# 8607

Monday, 06/17/2013 1:26:41 PM

Monday, June 17, 2013 1:26:41 PM

Post# of 426734
The PDUFA is 12-20-13.

Also, no PR on Adcom means no date set yet so the December you recall was likely speculation on a board or you are confusing it with PDUFA date

PRESS RELEASE EXCERPT
The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.
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