The U.S. Food and Drug Administration approved Neurelis Inc.’s Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older.
SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.
Acorda Therapeutics will terminate approximately 25 percent of headcount as the company initiates a corporate restructuring.
Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.
Zogenix plans to resubmit a New Drug Application for Fintepla (fenfluramine) to treat seizures associated with Dravet syndrome.
GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.
The U.S. FDA approved InvaGen Pharmaceuticals’ generic version of Pfizer’s Lyrica (pregabalin) for eight different dosages.
Zogenix Inc. intends to resubmit the company’s New Drug Application for Fintepla (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in third-quarter 2019.
UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.
GW Pharmaceuticals Plc said the company’s drug Epidiolex was successful in treating seizures in patients with a rare form of childhood epilepsy called tuberous sclerosis complex during a late-stage trial.
