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Complete Response for Rizaport Versafilm to treat migraine.- IntelGenx Technologies

Read time: 1 mins
Published:29th Mar 2020
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

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