20th Oct 2008 – (NASDAQ: TEVA) announced today that the US Food and Drug Administration (FDA) has granted approval for the company’s abbreviated new drug application (ANDA) for Fentanyl Transdermal System, 25 meg/hour, 50 meg/hour, 75 meg/hour and 100 meg/hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic(R). 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 US for the twelve months that ended 30 June 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 utilises 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.