OTC Labeling Exemption Requests For Ophthalmics Denied By FDA
This article was originally published in The Tan Sheet
Executive Summary
Two requests for exemptions from certain provisions of the OTC labeling final rule are denied by FDA in Aug. 23 letters to the applicant companies.
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An across-the-board variance allowing listing possible inactive ingredients on labeling of OTC drugs manufactured by multiple suppliers is requested in a citizen petition filed with FDA May 16. A slightly revised petition followed on May 23.
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An across-the-board variance allowing listing possible inactive ingredients on labeling of OTC drugs manufactured by multiple suppliers is requested in a citizen petition filed with FDA May 16. A slightly revised petition followed on May 23.