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FDA Approves Zogenix's Fintepla To Treat Seizures Associated With Dravet Syndrome

Zogenix Inc. (ZGNX) said that the U.S. Food and Drug Administration has approved Fintepla or fenfluramine oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

The company noted that Fintepla will be launched through a restricted distribution program, called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program, and is expected to be available through Zogenix's specialty pharmacy partner by the end of July.

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden unexpected death.

Fintepla will be available to certified prescribers in the U.S. in July. Zogenix is launching Zogenix Central, a comprehensive support service that will provide ongoing product assistance to patients, caregivers, and their medical teams.

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