Watson’s Generic VANCOCIN® HCl Capsules Receive FDA Approval
PARSIPPANY, N.J., April 10, 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 Vancomycin Hydrochloride Capsules, USP, 125 mg and 250 mg, generic versions of ViroPharma Incorporated’s VANCOCIN® HCl capsules. Watson began shipping the products immediately.
VANCOCIN® HCl capsules had total U.S. sales of $332 million for the twelve months ending February 29, 2012, according to IMS Health. VANCOCIN® HCl capsules are indicated for the treatment of C. difficile-associated diarrhea and also for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).
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 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 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, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
VANCOCIN® is a registered trademark of ViroPharma Incorporated.
CONTACTS: Investors: Patty Eisenhaur (862) 261-8141 Media: Charlie Mayr (862) 261-8030
SOURCE Watson Pharmaceuticals, Inc.