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Complete Response Letter from FDA for VersaFilm for Migraine- IntelGenx

Read time: 1 mins
Last updated:5th Feb 2014
Published:5th Feb 2014
Source: Pharmawand

IntelGenx Corp., a Canadian drug delivery company focusing on oral drug delivery, and RedHill Biopharma Ltd. , an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, announced that they received a Complete Response Letter from the FDA regarding the New Drug Application ("NDA") for their VersaFilm Oral Film Product for the treatment of acute Migraines.

The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm product primarily relate to third party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.

The rizatriptan film demonstrated bioequivalence in a successful pivotal clinical trial compared to the reference listed drug Maxalt MLT. IntelGenx submitted a 505(b)(2) New Drug Application for regulatory approval to the FDA in Q1 2013.

In addition to pursuing marketing approval in the U.S., and following a positive meeting with the German pharmaceuticals regulation authority BfArM in October 2013, IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application for marketing approval of the product in Europe later this year, with Germany as the reference member state under the European Mutual Recognition Procedure.

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