Teva granted FDA approval for Fentanyl transdermal system

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.

Total annual sales of this product for the strengths noted above, including both brand and generic sales, were approximately $1.2 billion in the United States for the twelve months that ended June 30, 2008, based on IMS sales data.

Teva's Fentanyl Transdermal System was developed and manufactured by Aveva Drug Delivery Systems, a Nitto Denko company, which is one of the world's largest manufacturers of, and a pioneer in, "drug in adhesive" transdermal patch technology. The product utilizes a proprietary matrix design which incorporates the drug into the adhesive. It 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 that cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

FDA's diligence in approving this ANDA ensures that patients continue to have access to this medicine.


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