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Acorda Therapeutics, Inc.
Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
April 17th, 2009
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that the Company received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The FDA has raised what it termed “format issues” regarding the eCTD (electronic) submission, requesting that some of the data in the NDA be reformatted, as well as requesting that some additional supporting information be included in the filing. The FDA has not requested or recommended additional clinical or other studies. “We are surprised by...
Source: Health Business Week (2009-04-17)
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