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WednesdayClinical Trials Necessary to Approve a Copaxone Generic
(Posted By: Josi Creek)
Any generic of Teva’s blockbuster multiple sclerosis treatment Copaxone would need clinical trials to gain approval, the company says in response to speculation that the FDA might approve a generic Copaxone using the same criteria it applied to generic Lovenox. “In the case of Copaxone and other complex molecules, there are no acceptable … tests either in humans or animals that can be relied upon except for complete clinical tests, which reflect the clinical outcome in multiple sclerosis,” Teva CEO Shlomo Yanai said. Labels: Study |