FDA grants Aquestive 7-year orphan drug exclusivity for Libervant in pediatric seizure clusters ages 2-5

Aquestive Therapeutics, Inc.

FDA granted 7 years of orphan drug exclusivity to Libervant (diazepam) Buccal Film for treating seizure clusters in patients aged 2-5.
Exclusivity extends to April 2031; FDA cited buccal route as major contribution to patient care vs rectal route.
Libervant is the first and only FDA-approved orally administered rescue therapy for this pediatric population.
Originally designated as orphan drug in 2016; ODE now granted following approval on April 26, 2024.

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