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# IntelGenx NDA Approved for Migraine Film
- URL: https://www.fdaweb.com/intelgenx-nda-approved-for-migraine-film/
- Published: 2023-04-18T12:00:00.000Z
- Updated: 2026-09-14T18:26:16.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5154243

FDA has approved an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating acute migraine. The company says RizaFilm is a proprietary orally disintergrating thin-film formulation of rizatriptan benzoate, the active ingredient in Merck’s Maxalt. IntelGenx says FDA completed a “successful pre-approval inspection” earlier in the month at its Montreal manufacturing facility that supported the product’s approval.

IntelGenx says it previously entered into a licensing, development and supply agreement with Gensco Pharma for the exclusive commercialization of the drug in the U.S. Under the agreement, IntelGenx will receive royalty payments based on net profits of RizaFilm, and is eligible to receive pre-specified payments upon reaching certain regulatory and commercial milestones.

According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading disability cause. RizaFilm was developed to relieve patients with nausea or difficulty swallowing, the company says.