Posted by Michael Wonder on 25 May 2022
Phathom Pharmaceuticals announces FDA acceptance for filing of vonoprazan NDA for the treatment of erosive oesophagitis
25 May 2022 - Phathom Pharmaceuticals announced today the U.S. FDA has accepted for review the company’s new drug application for vonoprazan as a treatment for adults for the healing of all grades of erosive oesophagitis and relief of heartburn, and maintenance of healing of all grades of erosive oesophagitis and relief of heartburn.
The FDA has assigned the application standard review and a Prescription Drug User Fee Act target action date of 11 January 2023.
