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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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.
Naloxone distribution programs ask that the cheaper generic injectable formulation have the same community-use language in its label as the nasal spray and auto-injector so they can maximize their distribution efforts.