The FDA accepted for review IntelGenx’s (TSX:IGX; OTCQB:IGXT) Class 2 response to a 2020 complete response letter for the company’s 505(b)(2) NDA for RIZAFILM VersaFilm for the treatment of acute migraine.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the review of the RIZAFILM NDA.
“We are pleased to receive confirmation that the FDA is commencing its review of our NDA resubmission, and are looking forward to continuing to work with the agency to make RIZAFILM VersaFilm available to acute migraine patients in the United States,” Dr. Horst Zerbe, CEO of IntelGenx, said in a statement.
