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March 3, 2014
08:15 EDTRDHLRedHill Biopharma, IntelGenx submit response to FDA CRL for VersaFilm product
IntelGenx announced, together with RedHill Biopharma that they submitted a response to the Complete Response Letter of the U.S. Food and Drug Administration for the New Drug Application for their VersaFilm Oral Film Product for the treatment of acute migraines.The companies previously reported on February 4 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL. IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm NDA, and will provide additional updates as and when applicable.
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