30.10.2023 14:04:55
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Phathom: FDA Approves Reformulated Vonoprazan Tablets For VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK
(RTTNews) - Phathom Pharmaceuticals, Inc. (PHAT) announced the FDA has approved the Prior Approval Supplement for the reformulation of vonoprazan tablets for both VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, for the treatment of Helicobacter pylori infection in adults. The company is planning for a December 2023 U.S. launch for H. pylori, together with the U.S. launch of vonoprazan for Erosive GERD, if approved.
The company plans to host an investor conference call in November 2023, following FDA action on the pending Erosive GERD New Drug Application, which has a PDUFA target action date of November 17, to discuss the U.S. commercial launch plans.
Shares of Phathom Pharmaceuticals are up 4% in pre-market trade on Monday.
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