FDA Requires Manufacturers to Provide Mail-Back Envelopes for Opioid Disposal
Approval of the modified Opioid Analgesic REMS is expected in 2024.
Approval of the modified Opioid Analgesic REMS is expected in 2024.
The product was designed using the Amphastar’s proprietary nasal delivery device.
Under the FDA’s orders, the Company may not market or distribute these products in the US.
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021.
In a recent social media video challenge, individuals were encouraged to cook chicken in NyQuil or another similar OTC cough and cold medication.
AD04 is a genetically targeted, serotonin-3 receptor antagonist that is believed to reduce alcohol intake by interfering with the dopamine reward system.
Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers.
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
Researchers used data from the State Unintentional Drug Overdose Reporting System in order to assess trends in gabapentin-involved overdose deaths.