Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has received US Food and Drug Administration (FDA) approval of its application to develop a generic version of birth control pill Yaz.
Based on IMS sales data, annual sales of Yaz were approximately $616 million in the United States in 2008.
Yaz (Drospirenone and Ethinyl Estradiol) tablets are developed by Bayer Healthcare Pharmaceuticals.
Jerusalem-based Teva said that the FDA has granted approval for the company's abbreviated new drug application (ANDA) to market its generic version for oral contraceptive Yaz. 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.
In 2008, Teva 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.
Shares in Teva rose 0.87% yesterday to $45.44, giving it a market cap of $40.38 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on April 2, 2009
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