BioCentury
ARTICLE | Company News

Eisai wants DEA to schedule Fycompa

August 19, 2013 11:30 PM UTC

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) asked the U.S. Court of Appeals for the District of Columbia to direct the U.S. Drug Enforcement Agency to schedule the pharma's Fycompa perampanel. FDA approved the epilepsy drug last October and sent its scheduling recommendation to the DEA in January. According to Eisai, the DEA has not yet started the scheduling process for Fycompa. The pharma wants the court to direct the DEA to issue a notice of proposed rulemaking for Fycompa's scheduling within 10 business days of an order, to provide a comment period of about 30 days and to issue a final rule for Fycompa within 45 days after the end of the comment period. ...