Phathom receives FDA complete response letters for vonoprazan NDAs due to nitrosamine impurity

Phathom Pharmaceuticals, Inc.

CRL for erosive esophagitis NDA and H. pylori post-approval supplement, citing impurity N-nitroso-vonoprazan (NVP).
FDA requests additional stability data showing NVP remains below acceptable intake throughout shelf life; no other deficiencies.
Phathom implemented mitigation measures and expects to meet with FDA in Q1 2023 to discuss resubmission timeline.
This follows January 2023 announcement; delays potential approval and commercial launch of vonoprazan products.

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