BioTuesdays

FDA accepts IntelGenx NDA resubmission for RIZAPORT

IntelGenx

The FDA accepted IntelGenx’s (TSXV:IGX; OTCQX:IGXT) 505(b)(2) NDA resubmission for RIZAPORT VersaFilm for the treatment of acute migraines.

The FDA also assigned a PDUFA goal date for completion of the NDA review of March 26, 2020.

“Our team’s tireless work has enabled a timely NDA resubmission that has addressed all of the agency’s questions, and we are very much looking forward to the FDA’s decision early next year,” CEO Dr. Horst Zerbe said in a statement.

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