Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee

 
• By Sarah Karlin-Smith

US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.

FDA Advisory Committee Feature image
Charleston was unsuccessful at its second advisory committee for Hydexor

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