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.
Seizure Disorders
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.
FDA Approves MRI Labeling for Neurostimulation System Designed to Prevent Seizures
The RNS System consists of a small neurostimulator that is surgically implanted into the skull, delivering an electrical stimulation to the brain via leads when abnormal activity is detected.
Valtoco Nasal Spray Now Available for Seizure Clusters
Neurelis announced the availability of Valtoco® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients aged ≥6 years.
Phenytoin Oral Suspension Recalled Due to Potential for Inaccurate Dosing
Taro Pharmaceuticals announced the voluntary recall of 2 lots of Phenytoin Oral Suspension 125mg/mL packaged in 237mL bottles that may not resuspend properly when shaken, which can potentially result in under or overdosing.
FDA to Review NDA for Libervant Buccal Film for Seizure Clusters
The Food and Drug Administration (FDA) has accepted for review the New Drug Application for Libervant® (diazepam; Aquestive Therapeutics) buccal film for the management of seizure clusters.
