Watson Receives FDA Approval For Generic ActosÂ®
PARSIPPANY, N.J., Oct. 26, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that Watson has launched a generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets) after receiving final approval today from the U.S. Food and Drug Administration (FDA). Watson began shipping the product immediately.
On August 15, 2012, Watson announced that it had filed suit against the FDA challenging the Agency's decision regarding Watson's entitlement to shared exclusivity for its generic version of Actos®. Mylan Pharmaceuticals, Inc. subsequently intervened as a defendant in the action. On October 22, 2012, the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson and ordered the FDA to approve Watson's ANDA. Mylan appealed the judgment to the U.S. Court of Appeals for the District of Columbia Circuit. The Court of Appeals has denied Mylan's motion for a stay of the judgment pending the appeal.
For the 12 months ending August 31, 2012, Actos® and its generic equivalents had total U.S. sales of approximately $2.7 billion, 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. The Company is also developing biosimilar products in Women's Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. 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 inherent uncertainty associated with financial projections; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the impact of competitive products and pricing; the timing and success of product launches; the inherent uncertainty of litigation, including the pending lawsuit and appeal related to Watson's pioglitazone product; 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 June 30, 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. Actos® is a registered trademark of Takeda Chemical Industries, Ltd.
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