Advisory meeting Oct 14, 2009. That was close. I was starting to worry about my Oct options.
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Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
Last update: 8/25/2009 9:25:00 AM
Peripheral and Central Nervous System Drugs Advisory Committee to Hold Meeting on October 14, 2009
HAWTHORNE, N.Y., Aug 25, 2009 (BUSINESS WIRE) -- --Proposed Trade Name for Fampridine-SR, if approved, is Amaya(TM)
Acorda Therapeutics, Inc. (ACOR) today announced that the U.S. Food and Drug Administration (FDA) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company's New Drug Application (NDA) for Fampridine-SR on October 14, 2009. The meeting will take place at the Inn and Conference Center, University of Maryland University College (UMUC), Marriott Conference Centers, 3501 University Blvd. East, Adelphi, MD. Information related to the meeting is available on the U.S. Office of the Federal Register web site at:
The Company also announced that it has received preliminary approval for the proposed trade name Amaya from the FDA.
Fampridine-SR is a novel therapy being studied as a potential treatment to improve walking ability in people with multiple sclerosis. The Fampridine-SR NDA was accepted by the FDA on May 5, 2009 and assigned Priority Review status. At that time, the FDA set 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 Fampridine-SR. |
