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OTC swimmer's ear monograph vacated by FDA; Del pursuing water-clogged ears indication.

This article was originally published in The Tan Sheet

Executive Summary

ISOPROPYL ALCOHOL/ANHYDROUS GLYCERIN GIVEN NONMONOGRAPH STATUS BY FDA in a final rule on over-the-counter topical otic drug products for the prevention of swimmer's ear or for the drying of water-clogged ears. Published in the Feb. 15 issue of the Federal Register, the final regulation states that "no active ingredient has been determined to be generally recognized as safe and effective for use in OTC topical otic drug products." The rule will become effective Aug. 15.
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