US FDA smacks Acorda with refuse to file letter for fampridine
This article was originally published in Scrip
Executive Summary
The US FDA has issued Acorda Therapeutics with a rare refuse to file letter for its lead development candidate, the multiple sclerosis therapy, Fampridine-SR (4-aminopyridine), for which it is seeking an indication of improving patients' walking abilities when used in combination with other MS drugs.