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Duragesic

Duragesic (or Durogesic in europe) is the trade name of a fentanyl transdermal therapeutic system manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica Products, L.P. A generic version was under development by Sandoz Laboratories, Inc, formerly Mylan Laboratories Inc. for launch in January 2005. The generic bioequivalent of Duragesic is available in 25, 50, 75, and 100 mcg dosages, while the trade name Duragesic is available in 12.5, 23, 50, 75, and 100 mcg dosages. more...

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The system employs a form-fill-seal technology in which a drug-laden gel is sealed between an impermeable backing and a drug-permeable release liner.

Durogesic D-Trans, available in some European countries, consists of a thinner, solid single-layer plastic patch with the fentanyl matrix-bonded in an adhesive layer.

During the period of June 2002 - June 2003, Duragesic sales totalled over one billion dollars.

Janssen Pharmaceutica Products, L.P., initiated a series of Class II Recalls in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the FDA.

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Mylan Technologies
From Drug Store News, 3/7/05 by James Frederick

The FDA granted approval to Mylan Technologies for the first generic version of Alza's Duragesic Patch (fentanyl transdermal system) for the treatment of severe chronic pain that cannot be managed with alternate analgesics. When applied to the skin, the patch technology delivers fentanyl, an opioid pain medication absorbed into the body through the skin, offering up to 72 hours of pain relief. At the same time the FDA approved Mylan s generic pain patch, it acted on several citizens' petitions requesting that the FDA deny or delay approval of e product. Mylan s pain patch, which began shipping last month, will compete with Sandoz's authorized generic version of the drug.

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

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