Watson Receives FDA Approval For Generic Duragesic(R)

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Aug 2007 - 0:00 PDT

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Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for fentanyl transdermal system in the 25, 50, 75 & 100 mcg/hour strengths. Fentanyl transdermal system is the generic equivalent to ALZA Corporation's Duragesic(R), which is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. For the 12-months ending June 2007, Duragesic(R) and generic equivalents had total U.S. sales of approximately $1.2 billion, according to IMS Health data.

"The approval of our fentanyl transdermal product is very gratifying and represents a significant addition to our broad and diverse generic product portfolio," said Allen Chao, Ph.D., Watson's Chairman and Chief Executive Officer. "Transdermal fentanyl, manufactured in our Salt Lake City, Utah facility, will be launched immediately and is expected to be an important contributor to our Generic Division."

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand 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 continued demand for Watson's products; difficulties or delays in manufacturing; 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 Annual Report on Form 10-K for the year ended December 31, 2006.

Watson Pharmaceuticals, Inc.
http://www.watsonpharm.com