Purdue Butrans Pediatric Study Added To Label – Sort Of
Executive Summary
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.
You may also be interested in...
Keeping Track: Industry Beefs Up 2020 Review Pipeline With Submissions Galore
The latest drug development news and highlights from our US FDA Performance Tracker.
Endo’s Opana IR Should Not Add Pediatric Data To Labeling, US FDA Panel Says
Incorporating data from two studies that raised safety and efficacy concerns would give a false sense of security about the drug’s use in pediatric patients, the panel majority said, while dissenters said some pediatric data in labeling is better than no information at all.
Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
The latest drug development news and highlights from our US FDA Performance Tracker.