PARSIPPANY, N.J., June 20, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dutasteride Capsules, 0.5 mg. Watson's Dutasteride Capsules product is a generic version of GlaxoSmithKline's AVODART(R), which is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
GlaxoSmithKline LLC filed suit against Watson on June 17, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its Dutasteride Capsules product prior to the expiration of U.S. Patent No. 5,565,467. GlaxoSmithKline's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until November 17, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending April 30, 2011, AVODART had total U.S. sales of approximately $580 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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|SOURCE Watson Pharmaceuticals, Inc.|
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