Teva Announces Approval of Generic Yaz Tablets
Wed, 04/01/2009 - 9:34am
Teva Pharmaceutical Industries Ltd. announced today that the FDA has granted approval for the company's Abbreviated New Drug Application (ANDA) to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz (Drospirenone and Ethinyl Estradiol) Tablets. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. Annual sales of Yaz® were approximately $616 million in the United States for the twelve months that ended December 30, 2008, based on IMS sales data. In 2008, Teva’s subsidiary Barr Pharmaceuticals, Inc. entered into a supply and licensing agreement with Bayer. Under this agreement, Teva has the right to launch an authorized generic version of Yaz® on July 1, 2011, or earlier in certain circumstances.