FDA approves Vonoprazan to treat erosive esophagitis

FDA approves Vonoprazan to treat erosive esophagitis

The U.S. Food and Drug Administration (FDA) approved Phathom Pharmaceuticals’ vonoprazan (Voquenza) on November 1, 2023 for the treatment of adults with erosive esophagitis (erosive GERD), a gastroesophageal reflux disease. The drug is expected to be commercially available by December 2023. The drug’s approval marks a critical moment for more than 20 million patients suffering …

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FDA Approves Reformulation of Vonoprazan Tablets for Therapeutic Treatment of Helicobacter Pylori

FDA Approves Reformulation of Vonoprazan Tablets for Therapeutic Treatment of Helicobacter Pylori

The FDA approved the Prior Approval Supplement (PAS) for reformulation of vonoprazan tablets for vonoprazan tablets, amoxicillin capsules, and clarithromycin tablets (Voquenza Triple Pak; Phathom Pharmaceuticals) as well as vonoprazan tablets and amoxicillin capsules (Voquenza Dual Pak; Phathom Pharmaceuticals) for the treatment of Helicobacter pylori (H. pylori) infection in adult patients. The treatment regimens contain …

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