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# IntelGenx Working on Rizaport NDA Resubmission
- URL: https://www.fdaweb.com/intelgenx-working-on-rizaport-nda-resubmission/
- Published: 2020-06-11T12:00:00.000Z
- Updated: 2026-09-14T16:17:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146984

IntelGenx says that a 6/10 meeting with FDA was “very productive” and the company is completing the work required to resubmit its Rizaport VersaFilm NDA as a treatment for migraine headaches. The company had received a 3/27 complete response letter indicating that the Rizaport VersaFilm NDA could not be approved in its current form. FDA asked for additional information and did not request a new bioequivalence study.

The company [says](https://www.marketwatch.com/press-release/intelgenx-provides-update-on-rizaportr-versafilmr-nda-resubmission-process-following-type-a-meeting-with-the-fda-2020-06-11-8184057?tesla=y&ref=fdaweb.com) that at the meeting it obtained clarification from FDA on the chemistry, manufacturing, and controls information that is needed for resubmission of the NDA.