Posted by Michael Wonder on 02 Sep 2017
Apricus Biosciences announces FDA acknowledgement of Vitaros Class 2 NDA resubmission
31 August 2017 - Apricus Biosciences today announced that the U.S. FDA has acknowledged receipt of its recently resubmitted new drug application for Vitaros (alprostadil, DDAIP.HCl) and considers it a complete, class 2 response to Apricus’ 2008 action letter.
The PDUFA goal date for completion of the FDA’s review of the Vitaros resubmission is set for 17 February 2018, which is the standard six month review period for NDA resubmissions.
