Mutual’s Mr. Mucus?
This article was originally published in The Tan Sheet
Executive Summary
United Research Labs/ Mutual Pharmaceutical have filed an ANDA for a generic version of Adams Respiratory Therapeutics single-ingredient, extended-release guaifenesin cough product Mucinex, the firms announce Aug. 18. Adams will urge FDA to apply the same "rigorous scientific criteria" Mucinex was subject to for its original OTC approval, the firm says the same day, noting Mutual's ANDA is for "an older, well-known matrix technology." Adams previously worked with the older technology, "but the FDA did not accept the resulting drug release profile and required a higher scientific standard for product approval," which led the firm to develop the bi-layer technology used in Mucinex, CEO Michael Valentino said during an Aug. 18 call. Mutual asserts its product will meet bioequivalence standards, Adams will "vigorously defend its exclusive market position" as well as its patent portfolio for the brand, Valentino says. Mucinex' approval drove a number of prescription guaifenesin products off the market (1"The Tan Sheet" March 3, 2003, p. 4)...