Posted by Michael Wonder on 10 Feb 2023
Phathom Pharmaceuticals provides regulatory updates
9 February 2023 - Phathom Pharmaceuticals today announced regulatory updates for its approved products, Voquenza Triple Pak and Voquenza Dual Pak, approved in the US for the treatment of H. pylori infection, and its pending new drug application for vonoprazan for the treatment of erosive oesophagitis.
Phathom has received complete response letters from the US FDA relating to its erosive oesophagitis new drug application and H. pylori post approval supplement, both of which address specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan, that was detected in the initial commercial launch materials of Voquenza Triple Pak and Voquenza Dual Pak.
