Acorda Drug Gets FDA Clearance – Analyst Blog
Zacks Market Commentaries (January 25th, 2010) Writes:
Recently, Acorda Therapeutics Inc. (ACOR) announced that the U.S. Food and Drug Administration (FDA) has cleared its oral drug Ampyra (dalfampridine) which aims to improve walking speed in patients suffering from multiple sclerosis (MS). The company expects to launch the drug in the United States in March 2010. Ampyra is the first drug to get FDA approval for treating walking impairment in MS patients.
Ampyra, previously known as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously referred to as fampridine. The drug enjoys orphan drug designation from the U.S. agency, thereby providing it with seven years of market exclusivity.
Ampyra will be manufactured under a license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (ELN). However, Ampyra will be marketed and distributed in the U.S. by Acorda.
Ampyra was found to be effective in patients with all four major
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