Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Ursodiol Tablets USP, 250 mg and 500 mg. Teva's Ursodiol Tablets are the AB-rated generic equivalents of Axcan's Urso 250® and Urso Forte®, which are indicated for treatment of patients with primary biliary cirrhosis. Shipment of this product has commenced.
The brand product had annual sales of approximately $76 million in the United States for the twelve months that ended March 31, 2009, based on IMS sales data.
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Teva Pharmaceutical Industries Ltd
View drug information on Urso.