Watson Receives Favorable Court Decision Regarding Generic Actos Approval
- Court Instructs FDA to Approve Watson's ANDA -
PARSIPPANY, N.J., Oct. 22, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that U.S. District Court for the District of Columbia has granted summary judgment in favor of Watson and ordered the U.S. Food and Drug Administration (FDA) to approve Watson's generic version of Actos® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets). Watson plans to begin shipping the product immediately upon receipt of final FDA approval.
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® (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets).
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.
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 inherent uncertainty of litigation, including the litigation against the FDA concerning Watson's ANDA for its pioglitazone product, and risks that Watson will not ultimately prevail in such litigation; 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; 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' and service providers' 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.
SOURCE Watson Pharmaceuticals, Inc.
Web Site: http://www.watson.com
Posted: October 2012