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Rx-to-OTC switch advisory committee meetings

This article was originally published in The Tan Sheet

Executive Summary

FDA's Nonprescription Drugs Advisory Committee will meet in closed session on July 28 to discuss "trade secret and/or confidential commercial information relevant to pending NDAs," according to a July 21 Federal Register notice. The advisory committee had been tentatively scheduled to review Burroughs Wellcome's Zovirax switch application on July 28 sandwiched between reviews of switch applications for SmithKline Beecham's Tagamet and Upjohn's Rogaine on July 27 and Merck's Pepcid on July 29 ("The Tan Sheet" June 27, p. 1). The Tagamet and Pepcid switches will be reviewed jointly with the Gastrointestinal Drugs Advisory Committee. For the Rogaine review, FDA has invited members from the Dermatologic Drugs Advisory Committee and the Cardiovascular and Renal Drugs Advisory Committee
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