FLORHAM PARK, N.J., Feb. 09, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced regulatory updates for its approved products, VOQUEZNA™ TRIPLE PAK™ and VOQUEZNA DUAL PAK™, approved in the U.S. for the treatment of H. pylori infection, and its pending New Drug Application (NDA) for vonoprazan for the treatment of erosive esophagitis. Phathom has received complete response letters from the U.S. Food and Drug Administration (FDA) relating to its erosive esophagitis NDA and H. pylori post approval supplement, both of which address specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP), that was detected in the initial commercial launch materials of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. These letters formalize FDA’s request, announced by the Company last month, that Phathom provide additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product. No additional deficiencies were cited by the FDA in either letter.
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Phathom Pharmaceuticals Provides Regulatory Updates
