Watson Receives Tentative Approval for Generic Ziac ANDA

The Food and Drug Administration (FDA) has tentatively approved Watson Pharmaceuticals Inc.'s (Corona, CA) abbreviated new drug application (ANDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 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.

Final FDA approval on Watson's ANDA may not be received until September 24, 2000, provided the FDA grants Lederle pediatric exclusivity. The FDA is currently reviewing Lederle's request for pediatric exclusivity and plans to make a determination on that request within 90 days. Once approved, the product will be manufactured by Watson's contract manufacturer, Aventis.

Watson Pharmaceuticals Inc. is engaged in the development, manufacture, and sale of proprietary and off-patent pharmaceutical products.

For more information: Watson Pharmaceuticals Inc., 311 Bonnie Circle, Corona, CA 91720. Tel: 909-270-1400. Fax: 909-270-1096.

Edited by Jim Pomager