MORRISTOWN, N.J., June 23 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) announced that its subsidiary, Watson Laboratories, Inc. has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Fentanyl Citrate Buccal tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg. Watson's Fentanyl Citrate Buccal tablets are a generic version of Cephalon's Fentora®. Fentora® is used to treat breakthrough pain (sudden episodes of pain that occur despite round-the-clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication.
Cephalon's legal action against Watson alleging that Watson's ANDA for Fentanyl Citrate Buccal tablets infringes certain of Cephalon's patents remains pending. Final approval of Watson's application remains subject to the expiration of the automatic stay of approval imposed under the provisions of the Hatch-Waxman Act.
For the twelve months ending April 30, 2010, Fentora® had total U.S. sales of approximately $170 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading 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 affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA 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' 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 annual report on Form 10-K for the year ended December 31,2009 and Watson's quarterly report on Form 10-Q for the period ended March 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Fentora® is a registered trademark of Cima Labs, Inc., a subsidiary of Cephalon, Inc.
SOURCE Watson Pharmaceuticals, Inc.