Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review

WASHINGTON, Jan. 8, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As previously reported, Vanda has sought approval from the U.S. Food and Drug Administration (FDA) for tradipitant for the treatment of patients with gastroparesis. FDA declined to approve Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis, providing Vanda with a Complete Response Letter (CRL) on Septe ...