FDA Cracks Down on Companies Selling Unapproved CBD Products
The products described in the warning letters are being marketed as topical pain therapies, though none have actually been evaluated by the FDA.
All articles by Diana Ernst, RPh
FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Aducanumab Gets Priority Review for Alzheimer Disease
The FDA has accepted for Priority Review the Biologics License Application for aducanumab (Biogen) for the treatment of Alzheimer disease.
Benefits Seen With Deutetrabenazine in Tardive Dyskinesia Regardless of Age
Treatment with deutetrabenazine was found to be beneficial for both younger (<55 years) and older (≥55 years) patients with tardive dyskinesia, according to findings from a recently published post hoc analysis.
FDA: Guidance on Digital Therapeutics for Psychiatric Disorders During COVID-19
The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
FDA Bans Electrical Stimulation Devices for Self-Injurious, Aggressive Behavior
The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
Troriluzole No Better Than Placebo in Generalized Anxiety Disorder Study
Results showed a mean change from baseline of -9.28 points (95% CI, -10.23 to -8.32) on the HAM-A total score in patients treated with troriluzole compared with -9.35 points (95% CI, -10.34 to -8.36) with placebo (P =.917).
FDA: Serious Complications Following Clozapine-Induced Constipation
The update was prompted by an FDA review of 10 cases of constipation in clozapine-treated patients that resulted in serious complications.
Alkermes Comes Under FDA Scrutiny for Vivitrol Ad Omitting Serious Warnings
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated.
Psilocybin Designated as Breakthrough Therapy for Depression
The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
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