CORONA, Calif., Dec. 16 Watson Pharmaceuticals,Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announcedthat its subsidiary, Watson Laboratories, Inc., has received approval todayfrom the United States Food and Drug Administration on its Abbreviated NewDrug Application (ANDA) for galantamine hydrobromide extended-releasecapsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantaminehydrobromide extended-release capsules are the generic equivalent to OrthoMcNeil Janssen's Razadyne(R) ER, galantamine HBr extended-release capsules,which are indicated for the treatment of Alzheimer's disease. Watson intendsto launch the product immediately. Razadyne(R) ER had annual sales ofapproximately $112 million for the twelve months ending September 2008,according to IMS sales data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leadingspecialty pharmaceutical company that develops, manufactures, markets, sellsand distributes generic and specialty brand pharmaceutical products. Watsonpursues a growth strategy combining internal product development, strategicalliances and collaborations and synergistic acquisitions of products andbusinesses. For press releases and other company information, visit WatsonPharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, the impact of competitive products and pricing; marketacceptance of and continued demand for Watson's products; difficulties ordelays in manufacturing; the difficulty of predicting the timing or outcome ofFDA or other regulatory agency approvals or actions, if any; patents and otherintellectual property rights held by third parties and the ability tosuccessfully enforce such rights against third parties; and other risks anduncertainties detailed in Watson's periodic public filings with the Securitiesand Exchange Commission, including but not limited to Watson's Annual Reporton Form 10-K for the year ended December 31, 2007.
Razadyne(R) ER is a registered trademark of Ortho-McNeil-JanssenPharmaceuticals, Inc.
SOURCE Watson Pharmaceuticals, Inc.