Supplement/OTC Combos Have Precedents In Other Categories, Firms State
This article was originally published in The Tan Sheet
Executive Summary
Prior sale of combination products such as drug/ devices or drug/biologics set a precedent for selling dietary supplement/OTC combination products, B.F. Ascher and Omni Nutraceuticals maintain in separate letters sent to FDA Nov. 6
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B.F. Ascher has discontinued the sale of its Melagesic PM dietary supplement/OTC combination in response to FDA's decision the product is an unapproved new drug, according to the agency
B.F. Ascher Halts Supplement/OTC Combo Sales Following FDA Warnings
B.F. Ascher has discontinued the sale of its Melagesic PM dietary supplement/OTC combination in response to FDA's decision the product is an unapproved new drug, according to the agency