The FDA announced today that it approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter, nonprescription use. Narcan rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. Approval allows direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod comes about six […]
Emergent BioSolutions
FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies. The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support […]
FDA accepts NDA for over-the-counter Narcan nasal spray from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) recently announced that the FDA accepted for review its over-the-counter Narcan (naloxone HCI) nasal spray. The FDA last week accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also granted the application priority review. If approved, it would represent the first 4 mg naloxone nasal spray […]
