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7 Results (showing 1 - 7)
Results sorted by updated date (newest first)
Results sorted by updated date (newest first)
Posted 5/26/2021 (updated 4/10/2024)
Posted 5/3/2021 (updated 4/10/2024)
The U.S. Food and Drug Administration (FDA) announced on April 30, 2021 the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.
Posted 8/4/2021 (updated 4/2/2024)
Posted 8/4/2021 (updated 4/2/2024)
Posted 1/19/2024 (updated 3/28/2024)
The FDA announced that the manufacturer of NARCAN 4 mg Nasal Spray products, Emergent BioSolutions, has extended the shelf-life of their product from 3 years to 4 years. This new extension of shelf-life was requested by the FDA to help prevent overdoses and reduce overdose-related deaths.
Posted 4/4/2023 (updated 3/27/2024)
… and Drug Administration (FDA) announced that the makers of Narcan, an opioid overdose treatment, have the agency’s … over the counter (OTC). Narcan is the brand name of the drug naloxone, a fast-acting overdose reversal. Until … varied by state – typically restricted to licensed health care providers, approved opioid overdose programs, and …
Posted 7/31/2023 (updated 3/26/2024)
At the end of July 2023, the U.S. Food and Drug Administration approved a second over-the-counter naloxone nasal spray product, RiVive. The agency who received the approval to manufacture the product, Harm Reduction Therapeutics, does not yet have a timeline of availability and decision on pricing.