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IntelGenx Facility Undergoes U.S. FDA Pre-Approval Inspection Related to RIZAPORT NDA
Jan. 30, 2019 08:53AM PST
Life Science Investing
IntelGenx (TSXV:IGX,OTCQX:IGXT) a leading oral drug delivery company, today announced that the U.S. Food and Drug Administration has performed a Pre-Approval Inspection of the company’s Health Canada-certified cGMP manufacturing facility in Montreal. As quoted in the press release: The PAI is related to the IntelGenx New Drug Application (“NDA”) for RIZAPORT®, a VersaFilm™ oral soluble …
IntelGenx (TSXV:IGX,OTCQX:IGXT) a leading oral drug delivery company, today announced that the U.S. Food and Drug Administration has performed a Pre-Approval Inspection of the company’s Health Canada-certified cGMP manufacturing facility in Montreal.
As quoted in the press release:
The PAI is related to the IntelGenx New Drug Application (“NDA”) for RIZAPORT®, a VersaFilm™ oral soluble film for the treatment of acute migraines. At the conclusion of the PAI on January 25, the FDA issued a Form 483 with five inspectional observations.
“We appreciate the thoroughness of the FDA’s review of our facility, and we are confident that we will be able to address the FDA’s observations within the 15-day response timeframe,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “As we continue to advance through the NDA process, IntelGenx is excited to have completed another important milestone toward U.S. approval.”