REYKJAVIK, Iceland, Aug. 22, 2007 (PRIME NEWSWIRE) -- Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Fentanyl Transdermal System. Distribution of the product will begin immediately.
Fentanyl Transdermal System is the generic equivalent of Alza/Janssen's Duragesic(r) and available in 25, 50, 75 and 100 mcg/hour strengths. Fentanyl Transdermal System 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.
Robert Wessman, President and CEO, said:
"The approval of fentanyl transdermal system signifies an important milestone for Actavis. The addition of transdermal fentanyl is representative of our continued effort to expand the depth and breadth of our product portfolio, and highlights our product development expertise in specialty generic products."
Annual brand and generic sales of fentanyl transdermal system in the U.S. were approximately US$1.2 billion for the twelve months ending June 2007 according to IMS health data.
About Actavis
Actavis is one of the world's leading generic pharmaceutical companies specializing in the development, manufacture and sale of generic pharmaceuticals. With headquarters in Iceland, Actavis has operations in 39 countries, with 11,000 employees. Actavis expects 2007 sales to total EUR1.6bn, with approximately one-third of these sales coming from the United States, the company's single largest market. In the U.S. alone, the company made 38 ANDA filings in 2006 and expects to file 40-45 in the year 2007 along with 18-20 new product launches. The company's U.S. operations are located in New Jersey, Maryland, North Carolina and Florida.
More information about Actavis can be found at www.actavis.us (U.S.) and www.actavis.com (Corporate).