IntelGenx (TSXV:IGX; OTCQB:IGXT) obtained clarity on the chemistry, manufacturing and controls information required for the resubmission of its RIZAPORT VersaFilm NDA during its Type A meeting with the FDA on June 10.
On March 27, 2020, IntelGenx received a complete response letter from the FDA regarding its resubmitted 505(b)(2) NDA for RIZAPORT VersaFilm for the treatment of acute migraines. The agency requested additional information, but no new bioequivalence study.
“The Type A meeting with the FDA was very productive and we are pleased with the outcome,” Dr. Horst Zerbe, CEO of IntelGenx, said in a statement.
“We are looking forward to completing the work required to resubmit our RIZAPORT VersaFilm NDA and remain committed to making this innovative new oral film product available to people suffering from migraines. We look forward to providing further updates on our progress as developments unfold,” he added.
