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FDA Approval Author: Staff Editor Last Updated: Nov 29, 2012 - 7:11:02 AM

Watson's Generic Revatio® Receives FDA Approval

By Staff Editor
Nov 12, 2012 - 12:21:18 PM

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( - PARSIPPANY, N.J., Nov. 12, 2012 -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc. has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Sildenafil Tablets, 20 mg, the generic equivalent to Pfizer's Revatio(®). Watson intends to begin shipping the product in the near future. Revatio(®) is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening.

For the 12 months ending September 30, 2012, Revatio(®) tablets had total U.S. sales of approximately $339 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. (NYSE: WPI) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.

Watson is the world's third-largest generics prescription drug manufacturer, with more than 750 products marketed globally through operations in more than 60 countries. Watson's global branded pharmaceutical business develops and markets products principally in Urology and Women's Health, and is committed to developing and marketing biosimilars products in Women's Health, Oncology and other therapeutic categories. In addition, Watson is the fourth-largest U.S. generic pharmaceutical product distributor through its Anda, Inc. business, and also develops and out-licenses generic pharmaceutical products outside of the U.S. through its Medis third-party business. Watson has announced that it will adopt a new global name - Actavis - effective in 2013.

Revatio(®) is a registered trademark of Pfizer, Inc.

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