Duragesic
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Duragesic 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 Mylan Laboratories Inc. for launch in January 2005.
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.
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.
External link
- FDA recall notice (http://www.fda.gov/medwatch/SAFETY/2004/duragesic.htm)