Watson Pharmaceuticals, Inc. Provides Update on Generic Lidoderm(R) Application
Published: Feb 03, 2012
PARSIPPANY, N.J., Feb. 3, 2012 /PRNewswire/ -- In response to investment community speculation following release of the transcript of a pre-trial conference call related to its Lidoderm® patent challenge, Watson Pharmaceuticals, Inc. (NYSE: WPI) today issued the following statement:
"Watson's abbreviated new drug application (ANDA) for a generic version of Lidoderm remains on track. We believe questions related to the site where a biostudy supporting the ANDA was conducted have been addressed to FDA's satisfaction. We continue to work closely with the FDA with the goal of timely approval. Watson has made public comments throughout the year regarding our Lidoderm application, including most recently at our analyst day on January 24th, where the Company restated our confidence that a tentative approval for generic Lidoderm will be received prior to the 30-month stay expiry on July 15, 2012.
"In order not to affect the pending patent litigation trial, it is our policy not to comment during litigation. Therefore, we will not provide additional comment on details that may arise during the trial."
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., is a leading integrated global pharmaceutical company. The Company is engaged in the development 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 Watson's estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to U.S. Food and Drug Administration (FDA) approval of Watson's generic version of Lidoderm, Watson's strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Watson's performance, at times, will differ from its goals and expectations. 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 inherent uncertainty associated with predicting the timing or outcome of product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation related to Watson's generic version of Lidoderm; the impact of competitive products and pricing; the timing and success of product launches; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Watson's facilities, products and/or businesses; changes in laws and regulations; 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, 2010 and its Quarterly Report on Form 10-Q for the period ended September 30, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Watson Pharmaceuticals, Inc.