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Ozone-depleting substances

This article was originally published in The Tan Sheet

Executive Summary

Epinephrine-containing OTC bronchodilator drugs will still be designated "essential" under FDA's final rule on use of chlorofluorocarbon propellants in self-pressurized containers. Primary OTC affected by rule appears to be Wyeth's Primatene Mist. Scheduled for publication in July 24 Federal Register, final rule differs only slightly from proposed version. Agency still will not eliminate essential-use designation for an active moiety approved under multiple NDAs until at least two alternatives that do not use ozone-depleting substances are available or, after Jan. 1, 2005, until "adequate alternatives" exist...
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