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Saturday 15 July 2006
Eon labs says generic muscle drug to be delayed
Eon Labs Inc. said its generic version of the Elan Corporation's Skelaxin muscle relaxant would be delayed after regulators rejected a study of the drug.
The Food and Drug Administration accepted Eon's application for the drug in 2001. After Elan filed a petition with the agency, the agency asked for another study on how the treatment worked in patients who had just eaten. The agency found that research unacceptable, the company said yesterday.
Eon, based in Laurelton, N.Y., has to prove the drug is an acceptable equivalent to Skelaxin to win F.D.A. approval. Its chief executive, Bernhard Hampl, would not predict how long that might take.