Watson Pharmaceuticals Receives FDA Approval For Generic Toprol XL(R) 25 MG And 50 MG

Main Category: Heart Disease
Also Included In: Hypertension;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 07 Aug 2009 - 1:00 PST

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Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Applications (ANDAs) for metoprolol succinate extended-release tablets USP in the 25 mg and 50 mg strengths. Metoprolol succinate extended-release tablets are the generic equivalent to AstraZeneca's Toprol XL(R) tablets. Metoprolol succinate extended-release is a beta-blocker used to treat angina, heart failure and high blood pressure. Watson intends to launch the product immediately.

Toprol XL(R) 25 mg and 50 mg and its generic equivalents had annual sales of approximately $628 million for the twelve months ending June 2009, according to IMS sales data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.

Forward-Looking Statement

Any statements contained in this press release that refer to future events 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. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. 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; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; and 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, 2009.

Toprol XL(R) is a registered trademark of AstraZeneca PLC.

Source: Watson Pharmaceuticals, Inc.