FDA’s Opioid Guidance: Industry Celebrates Multi-Tiered Labeling Cake
Endo says label differentiation in the guidance is a positive step; Commissioner Hamburg tells Congress that if new opioid formulations “significantly” deter abuse, generic versions will have to as well.
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The latest drug development news and highlights from our FDA Performance Tracker.
As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.
FDA sees progress on the opioid front with Zogenix and Teva the latest to seek abuse-deterrence claims, but is the existing science able to adequately fight abuse?