PARSIPPANY, N.J., July 11, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc - Florida has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium and Misoprostol Delayed-Release Tablets, the generic equivalent to G.D. Searle's ARTHROTEC®. Watson plans to launch the product in the fourth quarter of 2012.
For the twelve months ending May 31, 2012, ARTHROTEC® had total U.S. sales of approximately $130 million according to IMS Health data. ARTHROTEC® is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
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.
Forward-Looking Statement Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and Watson's Annual Report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
ARTHROTEC® is a registered trademark of G.D. Searle LLC, a subsidiary of Pfizer Inc.