Actavis Receives Approval Of Fentanyl Transdermal System In The U.S.

Main Category: Pain / Anesthetics
Article Date: 23 Aug 2007 - 0:00 PDT

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Actavis Group, the international generic pharmaceuticals company, 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 in the United States can be found at http://www.actavis.us.

Information in this press release may contain forward-looking statements with respect to the financial condition, results of operations and businesses of Actavis. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, exchange rate fluctuations, the risk that research and development will not yield new products that achieve commercial success, the impact of competition, price controls and price reductions, the risk of loss or expiration of patents or trade marks, difficulties of obtaining and maintaining governmental approvals for products, the risk of substantial product liability claims, exposure to environmental liability.

Actavis Group
http://www.actavis.com