J&J Duragesic “Black Box” Adds Fentanyl Abuse Warning
This article was originally published in The Pink Sheet Daily
Executive Summary
Revised labeling also narrows the indicated population and warns about drug-drug interactions with CYP 3A4 inhibitors. FDA notes J&J is in “discussions with the agency regarding establishment of a risk management program.” Labeling changes were approved one week after Duragesic generics entered the market.
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