Epidiolex Approved for Tuberous Sclerosis Complex-Associated Seizures
Epidiolex is a pharmaceutical formulation of highly purified cannabidiol.
Seizure Disorders
MPR Weekly Dose Podcast Episode 41
This week on the Pod: The FDA issues guidance for COVID-19 vaccine development; Accuracy in COVID-19 antibody testing; How statins may improve outcomes for hospitalized COVID-19 patients; and in non-COVID-related news there’s a new drug approvals in breast cancer and Dravet syndome.
New Treatment Option for Dravet Syndrome Approved
The FDA has approved Fintepla® (fenfluramine; Zogenix) oral solution for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
New Drug Product: Xcopri
This slideshow shows drug information for Xcopri. Click here for the complete Xcopri monograph. For a downloadable version of this slideshow, click here.
Unapproved Cannabidiol, Curcumin Injectables Marketed for Multiple Disorders Recalled
Biota Biosciences announced the voluntary recall of CBD Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables due to the products being marketed without the approval of the FDA.
Xcopri Now Available for Partial-Onset Seizures in Adults
SK Life Science has announced the availability of Xcopri (cenobamate) tablets for the treatment of partial-onset seizures in adults.
DEA Deschedules Prescription CBD Drug Epidiolex
Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration.
Epidiolex Gets Priority Review for Tuberous Sclerosis Complex-Associated Seizures
The FDA has accepted for Priority Review the supplemental New Drug Application for Epidiolex.
Epilepsy Therapy Xcopri Designated Schedule V Controlled Substance
The DEA has designated Xcopri (cenobamate; SK Life Science) as a schedule V controlled substance, indicating a lower potential for abuse.
