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news.Teva Pharmaceutical Industries has announced that the FDA has granted approval for the company's abbreviated new drug application for Fentanyl transdermal system, 25mcg/hour, 50mcg/hour, 75mcg/hour and 100mcg/hour, the AB-rated generic equivalent of Ortho McNeil's chronic pain treatment Duragesic. Shipment of this product has commenced.
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The Fentanyl transdermal system 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.
Teva’s Fentanyl transdermal system was developed and manufactured by Aveva Drug Delivery Systems, a Nitto Denko company, which is one of the manufacturers of ‘drug in adhesive’ transdermal patch technology.