May 06, 2009
FDA accepts NDA for Fampridine-SR, a treatment for spinal cord damageAcorda Therapeutics announced that the FDA has accepted for filing and granted priority review for the New Drug Application (NDA) submitted for Fampridine-SR (4-aminopyridine or 4-AP) sustained-release tablets. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Drugs granted priority reviews have a 6 month review clock as compared to a 10 month standard review.
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