Room Temperature Stable Fosphenytoin Gets FDA Approval
The product is a ready-to-dilute, room temperature stable formulation of fosphenytoin for IV injection, which allows for point-of-care storage.
Epilepsy
FDA Requires Boxed Warning Update for Benzodiazepines
Benzodiazepines are widely used to treat a variety of conditions including anxiety disorders, insomnia and seizures.
Epidiolex Approved for Tuberous Sclerosis Complex-Associated Seizures
Epidiolex is a pharmaceutical formulation of highly purified cannabidiol.
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.
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.
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.
Valtoco Nasal Spray Approved for Seizure Clusters
The FDA has approved Valtoco (diazepam nasal spray; Neurelis) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
Antiepileptic Drug Exposure Low in Breastfeeding Infants
Median percentage of infant-to-mother AED concentration ranged from 0.3 to 44.2 percent
Three Meds Equal as Second-Line Therapy for Status Epilepticus
Levetiracetam, fosphenytoin, valproate treat seizures unresponsive to benzodiazepine in children, adults.
