Posted by Michael Wonder on 21 Nov 2018
IntelGenx announces FDA’s acceptance of resubmission of new drug application for Rizaport
20 November 2018 - PDUFA goal date of 1 April 2019.
IntelGenx today announced that its 505(b)(2) new drug application resubmission for Rizaport oral soluble film 10 mg for the treatment of acute migraines has been accepted for review by the U.S. FDA.
The FDA has assigned a Prescription Drug User Fee Act goal date for completion of the review of the Rizaport application of 1 April 2019.
