Watson Receives FDA Approval For Generic Duragesic
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced recently 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 , 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 and generic equivalents had total U.S. sales of approximately $1.2B, 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 www.watsonpharm.com.
SOURCE: Watson Pharmaceuticals, Inc.