J&J Duragesic Shortage Resolved
This article was originally published in The Pink Sheet Daily
Short supply issues for Janssen's opioid analgesic transdermal patch are resolved. The company recalled lots of Duragesic in February and April due to possible medication leakage along one edge.
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Reports from a national drug abuse surveillance database are not sufficient basis for comparative safety claims between the Duragesic patch and other pain agents, FDA says. The agency asks J&J to devise a corrective action plan for a violative professional file card that was distributed beginning in 2003.
Additional lots of the 75 mcg/hour patches might leak medication along one edge. The recall now includes five lots of the chronic pain therapy shipped between December 2003 and March 2004.