FDA Puts Hold on Esophagitis, H pylori Drug

The regulatory delays stem from the presence of trace levels of a nitrosamine impurity that were initially detected in launch materials for two vonoprazan products from Phathom Pharmaceuticals.

Related Keywords

,Drug Administration ,Phathom Pharmaceutical ,Voquezna Triple Pak ,Voquezna Dual Pak ,Erosive Esophagitis ,Esophagitis ,Us Food And Drug Administration ,Nited States Food And Drug Administration ,Fda ,