ALBUTEROL TABS: FIRST ANDAs GO TO THREE GENERIC FIRMS: Sidmak Labs, American Therapeutics and Mutual Pharmaceutical Company. FDA approved the generic versions during the week ending Feb. 3 with a delay in marketing until Dec. 5, when Glaxo's patent on the tablet formulation of the bronchodilator expires. Albuterol is currently co-marketed by Glaxo and Schering-Plough under the brand names Ventolin and Proventil, respectively. In anticipation of generic competition, both companies have pursued new controlled-release formulations. Schering's b.i.d. Proventil Repetabs received FDA approval during the second half of 1987. Glaxo has an NDA pending for Volmax, a b.i.d. product using Alza's Oros system. Schering estimates that Proventil product line sales reached approximately $ 150 mil. in 1988. The Sidmak ANDA was technically the first approval, signed off on Jan. 30. The American Therapeutics and Mutual Pharmaceutical ANDAs were approved Feb. 2. Mutual Pharmaceutical is a four-and-a-half year old company located in Philadelphia. The firm says it has about 100 employees.
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