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 Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. Shipment of this product will begin immediately.
Teva’s product is the AB-rated equivalent of Pharmacia and Upjohn’s Xanax? XR Tablets, a product indicated for treatment of panic disorder.
Total annual sales of this product, including brand and generic sales, are approximately $54 million, based on IMS sales data.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva’s sales are in North America and Europe.