04 Apr 2009 11:00 AM
Teva Announces Approval Of Generic Yaz(R) Tablets
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) 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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's 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.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995…
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.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's 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.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995…

