Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf life
Submission of six-month stability data satisfies Phathom's stability data submission requirements for Erosive GERD New Drug Application (NDA) for vonoprazan with a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023
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