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Impax wins FDA approval for neuromuscular drug

Susan L. Thomas  

Impax Laboratories Inc. of Hayward said the U.S. Food and Drug Administration has approved its abbreviated new drug application for a generic version of Mestinon, a drug to treat a neuromuscular disorder, the company said Monday.

INC Pharmaceuticals Inc. markets Mestinon 60-milligram tablets for the symptomatic treatment of myasthenia gravis, a neuromuscular disorder characterized primarily by muscle weakness and rapid muscle fatigue. IMS Health puts U.S. sales of Mestinon at $19 million in 2002, according to Impax.