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Purdue Butrans Pediatric Study Added To Label – Sort Of

 
• By Laura Helbling

US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.

Crying Little Boy_1200

Purdue Pharma LP’s pain therapy Butrans (buprenorphine) has new pediatric labeling – but no specific information about the pediatric study itself.

On Oct. 13, the US FDA “approved” a supplement filed by Purdue seeking to include a description of a pediatric study of the drug (Study 3031)

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