Watson Pharmaceuticals has received final approval from 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 $1.2 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."
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