FDA accepts NDA for Libervant Buccal Film for the treatment of seizure clusters. -Aquestive Therapeutics.
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Eton Pharmaceuticals, Inc. announced that it has sold its neurology portfolio to Azurity Pharmaceuticals. The portfolio includes Eton’s lamotrigine (ET-105), zonisamide (ET-104), and topiramate (ET-101) product candidates, which have all been submitted to the FDA as new drug applications and are currently under review by the agency.
SK Biopharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of cenobamate for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-seizure medications (ASMs).