News
Complete Response for Rizaport Versafilm to treat migraine.- IntelGenx Technologies
IntelGenx Technologies announced that it has received a Complete Response Letter (“CRL”) from the FDA regarding its resubmitted 505(b)(2) New Drug Application (“NDA”) for Rizaport VersaFilm for the treatment of acute migraines.
The CRL states that the FDA cannot approve the application in its present form. The Agency requested additional information, but no new bioequivalence study.
Condition: Migraine/Headache
Type: drug