Resources
7 Results (showing 1 - 7)
Results sorted by updated date (oldest first)
Results sorted by updated date (oldest first)
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.
Posted 4/4/2023 (updated 3/27/2024)
The U.S. Food and Drug Administration (FDA) announced that the makers of Narcan, an opioid overdose treatment, have the agency’s approval to make the drug widely available over the counter (OTC). Narcan is the brand name of the drug naloxone, a fast-acting overdose reversal. Until now, availability varied by state – typically restricted to licensed health care providers, approved opioid overdose programs, and first responders. This is an important consideration for rural counties given that research shows that these areas are nearly three times more likely than metropolitan counties to be a low-dispensing county for naloxone.
Posted 5/26/2023 (updated 3/27/2024)
The U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to sever opioid use disorder (OUD). Buprenorphine is a safe and effective medication for OUD treatment.
Posted 2/28/2023 (updated 3/27/2024)
In November 2022, the FDA issued a letter providing information on the severe ulcerations that can occur from repeated xylazine exposure, withdrawal symptoms, and the interference xylazine can cause on successful treatment. The FDA continues to investigate the source of xylazine in the illicit drug supply. Health care professionals are strongly encouraged to report events in humans associated with xylazine exposure.
Posted 11/20/2023 (updated 3/28/2024)
The U.S. Food and Drug Administration cleared the use of Alltest Fentanyl Urine Test Cassette, which is the first over-the-counter test for the preliminary detection of fentanyl in urine. The test works by placing three drops of fresh urine onto a cassette containing a fentanyl test strip. After 5 minutes the test result will appear as colored lines. Although the test does not distinguish between certain drugs and medications.
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 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.