Posted by Michael Wonder on 29 Mar 2020
IntelGenx receives complete response letter from FDA for Rizaport NDA
27 March 2020 - IntelGenx today announced that it has received a complete response letter from the U.S. FDA regarding its resubmitted 505(b)(2) new drug application for Rizaport VersaFilm for the treatment of acute migraines.
The letter states that the FDA cannot approve the application in its present form. The agency requested additional information, but no new bioequivalence study.
