Watson Files FDA Application for Generic YAZ(R)
2007 NOV 19 -- Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty pharmaceutical company, confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of YAZ(R) tablets prior to the expiration of patents owned by Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. (Bayer). Bayer filed suit against Watson on November 5, 2007 in the U.S. District Court, District of Nevada, seeking to prevent Watson from commercializing its product prior to the expiration of patents numbered 6,787,531, RE 37,564 and RE 37,838. Bayer's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of FDA approval of Watson's ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner. YAZ(R) (drosperinone and ethinyl estradiol tablets) is indicated for the prevention of pregnancy. Keywords: Biotechnology, Drug Development, Generics, Pharmaceutical Business, Pharmaceutical Company, Regulatory Actions, Therapy, Treatment, Watson Pharmaceuticals Inc., Watson Pharmaceuticals Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.
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