FDA Strengthens REMS for Transmucosal Immediate-Release Fentanyl Products
While the use of TIRF medications has declined in recent years, data have suggested that prescribing of these drugs to patients who are not opioid tolerant still remains.
Narcotic Analgesics
FDA Rejects Zimhi NDA Again Citing New Issues
In the CRL, the FDA stated that the NDA could not be approved in its present form due to new issues pertaining to Chemistry, Manufacturing and Controls.
MPR Weekly Dose Podcast Episode 57
This week we cover a new treatment submission to the FDA for the prevention of diabetes; The launch of a bupivacaine implant to treat post op pain; The DEA schedules a newly approved opioid; The FDA classifies over 200 drugs as essential and wants manufacturers to ramp up production; And more news on rifamixin and other drugs that are in the pipeline.
DEA Schedules New IV Opioid Olinvyk
The FDA approved Olinvyk for acute pain severe enough to require an IV opioid analgesic and for whom alternative treatments are inadequate.
Most Users Report Cannabidiol Use for Treatment of Diagnosable Conditions
Psychiatric, orthopedic, and sleep issues most commonly cited in a Reddit forum
MPR Weekly Dose Podcast Episode 54
This week: News of another vaccine trial being put on hold; A trial assessing hyperimmue globulin beings; An NDA for IV tramadol is rejected; FDA Committees vote on novel schizophrenia and bipolar I disorder therapy; And a first approval for Ebola.
FDA Rejects IV Tramadol Over Potential Safety Concern
The FDA stated that IV tramadol is not safe for the intended patient population.
Opioid Analgesic Approvals Based on Limited Data, Study Says
Opioid products approved by the FDA between 1997 and 2018 relied on short- or intermediate-term studies that did not adequately analyze safety outcomes.
Dentists’ Rx for Opioids Pose Danger for Drug Interactions
In older adults, interactions with meds for depression, anxiety increase risk for ED visits, hospitalizations.
Fatal Medication Error: Ordinary Negligence or Professional Malpractice?
The nurse mistakenly administered 120 milligrams of morphine to the wrong patient.
