LIBERVANT® (diazepam) buccal film

Current Status: We have an important update 
regarding Libervant for children ages 2-5 years.

Due to a recent court decision, the FDA has changed Libervant's status to "tentative approval." This means that we are legally required to stop marketing the product in the United States until certain legal matters are resolved. This decision was not based on any safety or effectiveness concerns, but rather on technical legal matters.

Libervant (diazepam) buccal film is the first and only orally-administered, non-device diazepam treatment for seizure clusters (also known as acute repetitive seizures) in children ages 2-5 years. Delivered using Aquestive’s proprietary PharmFilm® technology, Libervant is a discreet, mint-flavored film that dissolves when placed inside the cheek, requiring no swallowing, chewing, or additional liquids. It offers a simple, syringe-free alternative to rectal delivery, with consistent absorption and demonstrated ease of use.

Prescribing Information

Important Safety Information

Medication Guide and
Instructions For Use

About acute repetitive seizures

Acute repetitive seizures (ARS) are sudden, recurring seizures that often occur without warning and require rapid intervention to prevent escalation. They represent a treatment challenge for patients with refractory epilepsy, particularly children, who may not respond to daily anti-epileptic medications. Left untreated, seizure clusters can lead to prolonged seizure emergencies, increased hospital visits, and a decline in quality of life.

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