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Watson Pharmaceuticals Receives FDA Final Approval for Generic Glucotrol XL(R) 10 mg Tablets

  [ 158 votes ]   [ Discuss This Article ] • November 13, 2003

CORONA, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), 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.

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.

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

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