Athena Diastat labeling should specifically define acute repetitive seizures, FDA advisory cmte. agrees.
Executive Summary
ATHENA DIASTAT LABELING SHOULD INCLUDE DESCRIPTION OF ACUTE REPETITIVE SEIZURES to clearly distinguish the indicated use of the anticonvulsant from other seizure types, FDA's Peripheral and Central Nervous System Drugs Advisory Committee agreed in recommending approval of the drug at its Nov. 15 meeting.