The FDA accepted IntelGenx’s (TSXV:IGX; OTCQX: IGXT) 505(b)(2) NDA resubmission of RIZAPORT oral soluble film 10 mg for the treatment of acute migraines.
The FDA also assigned a Prescription Drug User Fee Act (PDUFA) goal date for completing the review of the RIZAPORT NDA by April 1, 2019.
“We are pleased that the FDA has accepted for review the resubmission of the NDA for RIZAPORT, and will be working with the agency to achieve our goal of offering the first oral thin film on the market for the treatment of migraines,“ Dr. Horst Zerbe, CEO of IntelGenx, said in a statement.
