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Re: jbog post# 101118

Monday, 08/09/2010 4:03:11 PM

Monday, August 09, 2010 4:03:11 PM

Post# of 252313
Maybe this is the rumor???

FDA news Drug Daily Bulletin >

Teva: Clinical Trials Necessary to Approve a Copaxone Generic
FDAnews Drug Daily Bulletin
Aug. 6, 2010 | Vol. 7 No. 153



Teva: Clinical Trials Necessary to Approve a Copaxone Generic
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.

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