Posted by Michael Wonder on 22 Nov 2022
IntelGenx receives FDA PDUFA date for Rizafilm
22 November 2022 - IntelGenx today announced that the US FDA has accepted for review its Class 2 response to the 2020 complete response letter for its 505(b)(2) new drug application for Rizafilm VersaFilm.
The FDA has assigned a PDUFA goal date of 17 April 2023 for completion of the review of the Rizafilm new drug application.
