Vanda Pharmaceuticals announces FDA accepts NDA for tradipitant

Vanda Pharmaceuticals announced that the U.S. FDA has accepted the filing of Vanda’s New Drug Application for tradipitant for the treatment of symptoms of gastroparesis. The FDA has set September 18, 2024 as the target date for its decision under the Prescription Drug User Fee Act. If approved, tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years and to be accepted for review by the FDA for gastroparesis in over 30 years.