Amphastar Gets FDA Approval for Intranasal Naloxone Product
The product was designed using the Amphastar’s proprietary nasal delivery device.
The product was designed using the Amphastar’s proprietary nasal delivery device.
In 2011, following reports of serious livery injury, the FDA had required manufacturers of prescription acetaminophen combination products to limit the amount of acetaminophen to 325mg per tablet or capsule.
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.
The 2022 CDC Clinical Practice Guideline is intended to help clinicians weigh the benefits and risks of opioids and alternative pain treatments for outpatients.
Brightly colored versions of the synthetic opioid fentanyl are appearing across the US, according to the Drug Enforcement Administration (DEA). In a press statement, the Agency reported that the colorful fentanyl, dubbed “rainbow fentanyl”, has been seized in 18 different states and has been found in multiple forms, including pills, powder, and blocks that resemble…
Researchers used data from the State Unintentional Drug Overdose Reporting System in order to assess trends in gabapentin-involved overdose deaths.
The Strategy focuses on 2 main drivers of the opioid epidemic: drug trafficking and untreated addiction.
The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.
Naloxone Auto-Injector is specifically designed to be a medical countermeasure for military personnel or chemical incident responders against the potential threat of exposure to synthetic opioids on the battlefield.