The FDA has approved FINTEPLA® for LGS

March 28, 2022

The FDA has approved FINTEPLA® (fenfluramine) oral solution, CIV, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age and older. FINTEPLA is already approved as a treatment for Dravet syndrome in patients 2 years of age and older.

Please note that FINTEPLA is available only through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of valvular heart disease and pulmonary arterial hypertension.

Please see additional IMPORTANT SAFETY INFORMATION, including Boxed Warning, below.

Zogenix Central’s patient-focused model of care offers every family and their healthcare provider a dedicated Care Coordinator—a nurse trained in Dravet syndrome, Lennox-Gastaut syndrome, and FINTEPLA—who will remain constant throughout their entire FINTEPLA treatment journey. In addition, caregivers have 24/7/365 access to our Zogenix Central pharmacy team.

For more information, please contact Zogenix Central at 1-888-ZOGENIX (1-888-964-3649) or visit the website: Zogenix Central | Fintepla

 

FINTEPLA has demonstrated efficacy in the most difficult to treat seizure type