External Analgesic TFM To Exclude Patch, Plaster, Poultice Forms – Proposal
This article was originally published in The Tan Sheet
FDA is proposing to clarify the tentative final monograph for OTC external analgesic drug products to exclude topical patch, plaster and poultice dosage forms, according to a Jan. 17 Federal Register notice
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Petition Suggests US FDA Use Monograph Authority To Limit Indications For External Analgesic Patches
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.
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
U.S. Dermatologics' transdermal drug delivery platform is breathable and non-occlusive and should therefore be covered by the tentative final monograph for OTC external analgesics, the firm tells FDA in Sept. 30 comments