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...
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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