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.
Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration.
The FDA has accepted for Priority Review the supplemental New Drug Application for Epidiolex.
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.
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.
Median percentage of infant-to-mother AED concentration ranged from 0.3 to 44.2 percent
Levetiracetam, fosphenytoin, valproate treat seizures unresponsive to benzodiazepine in children, adults.
The Food and Drug Administration has granted Orphan Drug designation to STK-001 (Stoke Therapeutics) for the treatment of Dravet syndrome.
The FDA has accepted for review a New Drug Application for ET-105, a new liquid formulation of lamotrigine.
Findings seen among Dutch children exposed to one of four common antiepileptic drugs in utero
