IntelGenx Technologies Corp (IGXT)

[92662]

Warren N.J., Nov. 28, 2016 (GLOBE NEWSWIRE) -- MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Tadalafil PharmFilm for the treatment of erectile dysfunction.


“The filing of the NDA for Tadalafil PharmFilm is a significant milestone for MonoSol Rx and provides further evidence of the world-class capabilities of our development team. This application follows the successful completion of a pivotal pharmacokinetic study and a productive meeting with the FDA earlier this year,” said Dan Barber, Vice President of MonoSol Rx. “We believe that our product is well-positioned to compete in the multi-billion dollar erectile dysfunction market, based on its status as the first alternative to tadalafil tablets to file for FDA approval and our strong protective portfolio of patents. We look forward to working through the review process as we bring this innovative product to market.”

So much for IGXT being 1st to file. Behind the eight ball again.