US FDA Asks Sponsors Of Discontinued Naloxones To Consider Return To Market
In announcing expedited assessments for new naloxone ANDAs, the agency also offers guidance to sponsors of discontinued products considering a return to marketing.
You may also be interested in...
Emergent Expects Moving OTC Naloxone Directions On Package To Sway US FDA Advisory Panel
Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.
Naloxone OTC Switch NDA Has US FDA Concerned Labeling Will Cause User Error, Delay Delivery
CDER will ask advisory panel “whether additional labeling information might mitigate risk of use errors” for Emergent’s naloxone nasal spray made available OTC and whether results of firm’s human factors study “support that consumers are able to correctly administer nonprescription [naloxone nasal spray] in an emergency situation.”
US FDA's Words Matter: Sharpless Says Injectable Naloxone OK For Community Distribution
The acting commissioner's statement is intended to clarify "persistent misunderstanding" about the label for the opioid overdose rescue medication's injectable formulation.