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Novex Pharma labeling deferrals

This article was originally published in The Tan Sheet

Executive Summary

Canadian private labeler's deferral requests from OTC labeling final rule for Minoxidil Topical Solution 2% (Pharmacia's Rogaine Regular Strength for Men, Rogaine for Women) and Minoxidil Topical Solution 5% For Men (Rogaine Extra Strength for Men) are "appropriate," considering "the time that it has taken to finalize current FDA Drug Facts template labeling," agency says in Feb. 4 correspondence. Letter responds to Novex' Nov. 15 citizen petition. FDA has indicated it will revise the template for the 2% product; no template exists for the 5% version (1"The Tan Sheet" Dec. 10, 2001, p. 3)...

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