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Industry: Email Alert RSS FeedTentative approval for Watson's generic Ziac
Drug Store News, May 22, 2000 by Kim Roller, James Frederick
The FDA has tentatively approved Watson Pharmaceuticals' ANDA for bisoprolol Fumarate and Hydrochlorothiazide tab1ets, 2.5 mg/6.25 mg, 5 mg/6.25 mg and 10 mg/6.25 mg. Bisoprolol Fumarate and Hydrochlorothiazide is the generic equivalent to Lederle Laboratories' Ziac, which is used for the treatment of hypertension.
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The company said final FDA approval on its ANDA may not be received until September if the FDA grants Lederle pediatric exclusivity, which the agency is currently reviewing. Watson's product will be manufactured in Cincinnati by its contract manufacturer, Aventis.
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