The U.S. Food and Drug Administration approved Zogenix Inc.’s Fintepla (fenfluramine) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.
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.