New Opioid Labeling Further Constrains Use, Urges Prescribing Only By Docs ‘Knowledgeable’ About Risks
US FDA’s mandated labeling changes come after the agency required manufacturers to provide mail-back envelopes for opioid disposal.
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Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel
Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.
Califf Hints At Labeling Changes For Opioids And Chronic Pain
Califf also said the agency is open to endpoints other than abstinence for new opioid use disorder treatments at the fourth annual NIH HEAL Initiative Investigator Meeting.
‘Opioids’ Is Missing From The US FDA’s Overdose Prevention Framework Title On Purpose
Unlike prior plans, the FDA’s new substance abuse framework is intended to deal with stimulant and benzodiazepine use disorders, in addition to opioid abuse.