Phathom Pharmaceuticals Announces Submission Of Six-Month Stability Data In Support Of Erosive GERD New Drug Application
Portfolio Pulse from Benzinga Newsdesk
Phathom Pharmaceuticals has submitted six-month stability data for its Erosive GERD New Drug Application (NDA) for vonoprazan. The data remains more than 10x below the acceptable intake limit set by the FDA, supporting the requested product shelf life. This submission satisfies Phathom's stability data submission requirements for the NDA, with a PDUFA goal date of November 17, 2023.
August 21, 2023 | 12:14 pm
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Phathom Pharmaceuticals has met its stability data submission requirements for its Erosive GERD New Drug Application. This could potentially expedite the approval process.
The submission of the required stability data is a crucial step in the drug approval process. By meeting this requirement, Phathom Pharmaceuticals is potentially expediting the approval process for its Erosive GERD New Drug Application. This could have a positive impact on the company's stock in the short term.
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