Charleston's Anti-Emetic/Opioid Combo Flops At US FDA Panel Over Postmarketing, Dosage Concerns
Many of the advisory panel members felt the company's proposed buy-back program could not be feasible in practice.
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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.
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