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

Executive Summary

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.

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