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 Jim Kelly | Mar 2, 2023 | News
Drug companies could have made naloxone more accessible. Why didn’t they? https://www.washingtonpost.com/opinions/2023/01/23/naloxone-over-the-counter-opioid-overdose-antidote/#new_tab
FDA Fast-Tracks Review of Overdose Drug Naloxone for Use Without Prescription by Jim Kelly | Jan 3, 2023 | News
New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA by Jim Kelly | Jan 3, 2023 | News
