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.
