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Actavis receives approval of Fentanyl Transdermal System in the US |
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23 Aug 2007 |
Actavis today announced that it has received approval from the US Food & Drug Administration to market Fentanyl Transdermal System. Distribution of the product will begin immediately
HAFNARJORDUR, Iceland | August 22, 2007 | Actavis today announced that it has received approval from the US 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® 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 US were approximately US$1.2 billion for the twelve months ending June 2007 according to IMS health data. More information about Actavis in the United States can be found at www.actavis.us.
SOURCE: Actavis |
