After US FDA Advisors Unanimously Back First OTC Naloxone Proposal, Meeting On Second Not Needed

“Meeting is no longer needed,” agency states in announcement. The same committees’ unanimous recommendation during a meeting in February on Emergent’s sNDA for OTC sales of 4-mg naloxone nasal spray made a repeat for HRT’s NDA for 3-mg spray unnecessary.

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Harm Reduction Therapeutics Inc. doesn’t have to make an advisory committee presentation for its proposal for an OTC naloxone nasal spray, but still must wait for a US Food and Drug Administration decision it’s confident will be for approval.

The FDA on 1 March announced it cancelled the meeting of its Nonprescription Drug and Anesthetic and Analgesic Drug Products...

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