FDA Delays ruling on Acorda's MS Drug Until January
Thu, 10/22/2009 - 4:20am
HAWTHORNE, N.Y. (AP) — Acorda Therapeutics Inc. said Thursday the FDA delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months. The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010. Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug. Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.