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Biotech / Medical : Acorda Therapeutics Inc.

ACOR 0.880

-13.8%

Apr 10 5:00 PM EST

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From: kenhott	5/6/2009 6:18:36 AM
	of 120

Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing * FDA Assigns Priority Review and PDUFA Date of October 22, 2009 * No Current Therapies Indicated to Improve Walking Ability in People with MS HAWTHORNE, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of the Fampridine-SR NDA. “I am pleased that we were able to work quickly to address the comments from the FDA and resubmit our NDA approximately three weeks from having received the Refuse to File letter on our initial NDA submission, and that the FDA accepted the filing less than two weeks later,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO. “We are also encouraged that the FDA has elected to assign Priority Review status to the Fampridine-SR NDA.”

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