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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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Varying Inactive Ingredient Listing On OTC Labeling Requested

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.

Varying Inactive Ingredient Listing On OTC Labeling Requested

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.

Varying Inactive Ingredient Listing On OTC Labeling Requested

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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