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Petition Suggests US FDA Use Monograph Authority To Limit Indications For External Analgesic Patches

Executive Summary

Citizen petition suggests safety evidence lacking to affirm GRASE for some indications for patch, plaster or poultice dosage forms of OTC external analgesics. CHPA counters that petition inaccurately compares common OTC products with Rx drugs.

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External Analgesic Alternate Dosage Forms Supported By Recent Data – CHPA

CHPA requests that FDA withdraw its proposal to exclude patches, plasters and poultices from the OTC external analgesics tentative final monograph in Oct. 15 comments

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