Keeping Track: FDA Issues Three Four-Month Approvals: Ninlaro, Darzalex, And Narcan Nasal Spray
The latest drug development news and highlights from our FDA Performance Tracker.
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US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
Advisory committees will weigh adequacy of current pharmacokinetic requirements and pediatric dosing for novel formulations of the opioid overdose reversal agent.
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.