FDA Requires Manufacturers to Provide Mail-Back Envelopes for Opioid Disposal
Approval of the modified Opioid Analgesic REMS is expected in 2024.
Diagnosis & Disease Information
Amphastar Gets FDA Approval for Intranasal Naloxone Product
The product was designed using the Amphastar’s proprietary nasal delivery device.
FDA Issues Marketing Denial Orders for 2 Menthol E-Cigarette Products
Under the FDA’s orders, the Company may not market or distribute these products in the US.
RiVive Nasal Spray Gets Priority Review for OTC Treatment of Opioid Overdose
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
Buprenorphine Extended-Release SC Injection Under Review Again for Opioid Use Disorder
The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021.
FDA Warns of New Social Media Challenge With OTC Cough, Cold Medications
In a recent social media video challenge, individuals were encouraged to cook chicken in NyQuil or another similar OTC cough and cold medication.
Genetically Targeted Therapeutic Looks Promising for Alcohol Use Disorder
AD04 is a genetically targeted, serotonin-3 receptor antagonist that is believed to reduce alcohol intake by interfering with the dopamine reward system.
FDA: JUUL E-Cigarette Products Banned in US
Individual consumers are not restricted from having or using JUUL products; however, the Agency will ensure compliance by retailers.
Nalmefene HCl Injection Now Available for Opioid Overdose Treatment
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
Gabapentin-Involved Overdose Deaths Increased Between 2019 and 2020
Researchers used data from the State Unintentional Drug Overdose Reporting System in order to assess trends in gabapentin-involved overdose deaths.
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