Amphastar Gets FDA Approval for Intranasal Naloxone Product
The product was designed using the Amphastar’s proprietary nasal delivery device.
Diagnosis & Disease Information
FDA Limit on Acetaminophen in Combo Opioid Products Linked to Liver Injury Decline
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 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.
CDC Releases Updated Guidance on Prescribing Opioid Pain Medication
The 2022 CDC Clinical Practice Guideline is intended to help clinicians weigh the benefits and risks of opioids and alternative pain treatments for outpatients.
DEA: “Rainbow Fentanyl” a Deliberate Tactic to Target Young People
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…
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.
White House Releases Detailed Plan to Tackle the Overdose Epidemic
The Strategy focuses on 2 main drivers of the opioid epidemic: drug trafficking and untreated addiction.
FDA Considers Mail-Back Envelope as New Disposal Method for Opioids
The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.
FDA Approves Naloxone Auto-Injector as Countermeasure to High Potency Opioids
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.
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