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Butrans Pediatric Labeling Draws Mixed Views At US FDA Panel

 
• By Sue Sutter

Opponents say including data from a small pediatric trial of Purdue's buprenorphine patch could give the impression the study was more robust than it actually was, while supporters say labeling should reflect any available data that can inform pediatric prescribing.

Small kid taking a view of a plastic house.

A US FDA advisory committee's divided opinion on adding pediatric study data to Purdue Pharma LP's Butrans (buprenorphine extended release transdermal) labeling reflects a struggle between the desire to give healthcare providers all available information on dosing and safety in children and the concern that pediatric labeling would expand off-label use in this population.

At a Sep. 14 meeting, FDA asked its Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees whether information from Study 3031, a small pediatric trial,...

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