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 advisory committees to consider HRT’s new drug application for a 3-mg naloxone nasal spray scheduled 20 March. “The meeting is no longer needed,” the agency states in the announcement scheduled for publication in the Federal Register on 2 March.

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 advisory committees to consider HRT’s new drug application for a 3-mg naloxone nasal spray scheduled 20 March. “The meeting is no longer needed,” the agency states in the announcement scheduled for publication in the Federal Register on 2 March.

by | Mar 2, 2023 | News