Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application(ANDA) to market terbinafine hydrochloride tablets, 250 mg, the AB-rated generic equivalent of Novartis' antifungal agent Lamisil tablets. Shipment of this product will begin immediately.
Total annual sales of the brand product are approximately $685 million for the twelve months ended March 31, 2007, in the US based on IMS sales data.
Teva Pharmaceutical 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 76 per cent of Teva's sales are in North America and Europe.