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Prilosec 1 “approvable”

This article was originally published in The Tan Sheet

Executive Summary

P&G expects final approval of OTC Prilosec (omeprazole) for prevention of frequent heartburn early in the first quarter of 2003, firm says following Aug. 8 FDA letter deeming drug "approvable" pending label modifications and a label comprehension study. Company says FDA's correspondence gives it a "much better understanding of what is needed in a label comprehension study." In June, agency advisory committee members voted 16-2 in favor of switching the proton pump inhibitor OTC, but recommended significant labeling changes and an additional comprehension study (1"The Tan Sheet" June 24, 2002, p. 3). FDA's letter came three days after P&G told analysts during its Aug. 5 fiscal year-end earnings call that it hoped for final OTC approval before 2003 (2"The Tan Sheet" Aug. 12, 2002, p. 7)...

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