OTC Switch For Naloxone Finding Interest Among Sponsors
Now that US FDA is about to complete label comprehension study, sponsors seem more positive about OTC versions of naloxone products.
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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.
Trials will be mandated as part of new authority granted by SUPPORT Act and are intended to determine whether opioid efficacy decreases with long-term use.