Mylan Receives Approval on Bisoprolol Fumarate and Hydrochlorothiazide Tablets.Business Editors PITTSBURGH--(BUSINESS WIRE)--Sept.25, 2000 Mylan Laboratories Inc. (NYSE NYSE See: New York Stock Exchange :MYL) announced today that the Food and Drug Administration has approved Mylan's abbreviated new drug application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for Bisoprolol Fumarate and Hydrochlorothiazide hydrochlorothiazide /hy·dro·chlo·ro·thi·a·zide/ (-klor?o-thi´ah-zid) a thiazide diuretic, used for treatment of hypertension and edema. hy·dro·chlo·ro·thi·a·zide n. Abbr. Tablets, 2.5 mg/6.5mg, 5 mg/6.5 mg, and 10 mg/6.5 mg. Bisoprolol Fumarate and Hydrochlorothiazide is the generic equivalent to Lederle Laboratories Ziac(R) Tablets, which are indicated for the management of hypertension. This product will be manufactured at Mylan's Morgantown, West Virginia facility and shipment will begin immediately. This and past press releases of Mylan Laboratories Inc. are available at Mylan's web site at www.mylan.com. |
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