Teva gets FDA appro for generic Yaz
The US Food and Drug Administration has granted approval for Israeli generics giant Teva Pharmaceutical Industries' Abbreviated New Drug Application to market a copy version of Bayer Healthcare's oral contraceptive Yaz (drospirenone and ethinyl estradiol). 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 US sales of Yaz were around $616.0 million in the 12 months that ended December 30, 2008, based on IMS Health sales data.
Last year, Teva's subsidiary Barr Pharmaceuticals entered into a supply and licensing agreement with Bayer, under which Teva has the right to launch an authorized generic version of Yaz on July 1, 2011, or earlier in certain circumstances.
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