Acorda received a refuse to file (RTF) letter for the Fampridine-SR new drug application (NDA) on March 30, 2009, which cited the need to correct ‘format issues’ and requested additional supporting information before the NDA could be accepted for review.
Based on subsequent discussions with the FDA, Acorda has resubmitted the Fampridine-SR NDA and believes that all of the agency’s comments related to the RTF have been addressed.