FDA approves drug for severe epilepsy

Onfi approved for Lennox-Gastaut syndrome

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

"This is a difficult condition to treat, and it will be helpful to have an additional treatment option," FDA Division of Neurology Products director Russell Katz said.


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