Prilosec OTC launch
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA clears AstraZeneca/Procter & Gamble's proton pump inhibitor omeprazole June 20 for over-the-counter treatment of frequent heartburn. The approval follows the sponsors' completion of a patient labeling comprehen-sion study requested by FDA in an Aug. 8, 2002 "approvable" letter. The firms expect to launch Prilosec OTC 20 mg tablets in the fal