31 August 2022 - Libervant US market access currently subject to the expiration of Valtoco orphan drug market exclusivity.

Aquestive Therapeutics announced today that the US FDA has granted tentative approval for Libervant (diazepam) buccal film 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 patients with epilepsy 12 years of age and older.

Read Aquestive Therapeutics press release