IntelGenx Corp. announced that the U.S. Food and Drug Administration (FDA) has performed a Pre-Approval Inspection (PAI) of the company’s Health Canada-certified cGMP manufacturing facility in Montreal. 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. The FDA has assigned a Prescription Drug User Fee Act goal date of April 1, 2019, for completion of the review of the resubmitted NDA for RIZAPORT®. IntelGenx does not expect the inspectional observations to impact the timeline for the FDA’s decision on the approval of RIZAPORT®. In December 2018, IntelGenx entered into a definitive licensing, development and supply agreement granting Gensco® Pharma the exclusive right to commercialize the IntelGenx RIZAPORT® product in the United States.