Naloxone Sponsor Steps In Pricing Hole Disputing FDA's Cost Estimates
While arguing that US FDA overestimated inflation and fill rates when calculating annual cost of co-prescribing naloxone with opioids, Adapt Pharma opened door to pricing pledge questions that the Narcan sponsor could not answer.
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US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.