Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Proscar (Finasteride) tablets, 5 mg. Shipment of this product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded 180 days of marketing exclusivity.
Teva's Finasteride tablets USP are indicated for treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and to reduce the risk of the need for prostate surgery.
Annual brand product sales in the US were approximately $406 million for the twelve months ended March 2006, based on IMS 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 per cent of Teva's sales are in North America and Europe.