Phathom Pharmaceuticals, Inc received complete response letter from US FDA for its approved Helicobacter pylori drug products due to presence of N-nitroso-vonoprazan (NVP), nitrosamine impurity

Phathom has conducted extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of NVP below the acceptable intake. Phathom expects to meet with the FDA in the first quarter of this year to discuss the resubmission plan and timeline that the Company believes will lead to approval and launch of products containing vonoprazan.