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FDA delays ruling on Acorda’s MS drug until 1/2010

• Caroline says: The FDA has delayed their ruling on fampridine-sr, the walking drug from Acorda. The ruling was supposed to be made Oct 22, but Acorda has submitted some new risk-evaluation data so the decision is delayed.

October 22, 2009 6:38 AM ET

HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration 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.

View full post here: http://news.moneycentral.msn.com/provider/providerarticle.aspx?feed=AP&date=20091022&id=10582834

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