The FDA has approved Zogenix’s Fintepla (fenfluramine) for seizures associated with Dravet syndrome, a rare form of epilepsy, in patients age 2 years and older.

The approval was based on the results of two clinical trials, in which patients treated with Fintepla had significantly greater reductions in seizures than those who received a placebo.

The FDA is requiring a boxed warning for the drug on the risk of heart disease and hypertension.