The FDA has granted IntelGenx Technologies’ (TSXV:IGX; OTCQX:IGXT) request for a Type A meeting to discuss the company’s RIZAPORT VersaFilm program. The meeting is scheduled for June 10, 2020.
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.
In a statement, Dr. Horst Zerbe, CEO, said, “We are looking forward to meeting with the FDA to obtain clarification on its concerns regarding our resubmitted RIZAPORT VersaFilm NDA, so we can provide them with the additional information they require and determine the remaining steps required to obtain approval.”
