IntelGenx Technologies Corp. said the U.S. Food and Drug Administration has accepted its resubmitted new drug application for Rizaport VersaFilm, an oral soluble film for acute migraine.
The Montreal-based pharmaceutical company resubmitted the application for the drug in September after it was rejected a second time by the regulator in April.
Earlier rejections by the FDA were based on the regulator's concerns regarding chemistry, manufacturing and controls. The agency also requested additional information regarding the treatment, a proprietary oral thin film formulation of rizatriptan benzoate — the active drug in Merck & Co. Inc.'s Maxalt.
IntelGenx develops oral films — treatments that dissolve in the mouth, delivering certain medicines — using its VersaFilm technology platform.