Watson Pharmaceuticals, Inc.'s Generic Version of Pulmicort RESPULES® Receives FDA Approval
Published: Aug 01, 2012
PARSIPPANY, N.J., Aug. 1, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Budesonide Inhalation Suspension 0.25mg/2mL and 0.5mg/2mL Unit-dose ampules, the generic equivalent to AstraZeneca's Pulmicort RESPULES®. Watson is currently involved in patent litigation with AstraZeneca concerning this product. Watson plans to launch the product in 2012 subject to obtaining a favorable outcome on an anticipated motion for a preliminary injunction in the pending litigation.
For the twelve months ending May 31, 2012, Pulmicort RESPULES® had total U.S. sales of approximately $1.1 billion according to IMS Health data. Pulmicort RESPULES® is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
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 difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; the difficulty of predicting the timing and outcome of the pending patent litigation and risks that an adverse outcome in such litigation could render Watson liable for substantial damages; 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 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.
Pulmicort RESPULES® is a registered trademark of the AstraZeneca group of companies.
SOURCE Watson Pharmaceuticals, Inc.