Watson Confirms FDA Denies Appeal Related to Prochieve NDA for the Prevention of Preterm Birth
PARSIPPANY, N.J., Oct. 26, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that the U.S. Food and Drug Administration (FDA) denied the Company's Formal Dispute Resolution Request (FDRR) related to its pending New Drug Application (NDA) for Prochieve for the prevention of preterm birth in women with a short cervical length. The Company said it intends to review possible options related to the continued pursuit of the NDA. Watson filed its FDRR in August of 2012.
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. 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 impact of competitive products and pricing; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions if any; market acceptance of and continued demand for Watson's products; successful compliance with governmental regulations applicable to Watson's facilities, products and/or businesses; 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 period 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.
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Posted: October 2012