OxyContin Repeat? US FDA Seeks To Avoid Fallout Over Butrans Pediatric Data

Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.

A US FDA advisory committee meeting Sept. 14 to review new pediatric study data for Purdue Pharma LP's Butrans (buprenorphine extended-release) seems aimed at heading off the type of public outcry that followed approval of a pediatric claim for the company's OxyContin (oxycodone extended-release).

FDA is asking its Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees to discuss a...

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