The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.

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.

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.