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Watson Pharmaceuticals, Inc. Receives FDA Final Approval For Generic Glucotrol XL(R) 10 Mg Tablets

Published: Nov 10, 2003

CORONA, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for glipizide extended-release tablets in the 10 mg strength. Glipizide extended-release is the generic equivalent of Pfizer Inc.'s Glucotrol XL(R) and is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with type 2 diabetes after an adequate trial of dietary therapy has proved unsatisfactory. For the 12-months ending September 2003, Glucotrol XL(R) had sales of approximately $345 million, according to IMS data.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO )

Watson received final approval of its 5 mg glipizide extended-release product on September 8, 2003. Watson plans to launch its 5 mg and 10 mg glipizide extended-release product late in the fourth quarter 2003.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes branded and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com/ .

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 demand for Watson's products, and 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, 2002 and its Quarterly Report on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2003.

Glucotrol XL(R) is a registered trademark of Pfizer, Inc.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comWatson Pharmaceuticals, Inc.

CONTACT: Investors, Patty Eisenhaur +1-909-493-5611, or Media, ChrisEso, +1-909-493-4013, both of Watson Pharmaceuticals, Inc.

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