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FDA Action Alert: Aquestive, Eton and Mesoblast

September 28, 2020

Via: BioSpace

The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.

Aquestive’s Libervant for Management of Seizure Clusters in Epilepsy

Aquestive Therapeutics, based in Warren, New Jersey, had a target action date of September 27, 2020 for Libervant. The is a dose of enzodiazepine that is administered using a soluble film that is placed inside the cheek. It is intended for treatment of acute uncontrolled seizures in selected, refractory patients with epilepsy on stable regimens of AEDs who need intermittent diazepam to control increased seizure activity. The current standard of care rescue therapy for this indication is Diastat (diazepam rectal gel).

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