Prilosec OTC Review: Two Advisory Cmte. Members Weigh In Without Voting
An upcoming publication by FDA's Gastrointestinal Drugs Advisory Committee chairman will suggest a potential link between proton pump inhibitor therapy and the proliferation of pre-existing esophageal adenocarcinoma
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AstraZeneca/Procter & Gamble's Prilosec should remain a prescription-only medication pending revisions to the proposed OTC label, a joint FDA advisory committee suggested June 21
Gastroesophageal reflux disease is appropriate for OTC treatment, but AstraZeneca/Procter & Gamble's NDA to switch Prilosec OTC is not approvable, FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees voted at a joint meeting Oct. 20.
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