Posted by Michael Wonder on 12 Jun 2023
Phathom Pharmaceuticals announces FDA acceptance of NDA resubmission for erosive GERD
12 June 2023 - PDUFA goal date of 17 November 2023.
Phathom Pharmaceuticals today announced that the US FDA has acknowledged that its new drug application resubmission for vonoprazan, a novel first-in-class potassium-competitive acid blocker, for the treatment of erosive gastro-oesophageal reflux disease) constitutes a complete response to the February 2023 complete response letter.
