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Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Executive Summary

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 14.

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