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Jan 14, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Copaxone glatiramer acetate regulatory update

Teva sent a Citizen's Petition to FDA asking the agency to "refrain from approving" any multiple sclerosis drug unless the product has been reviewed by the Peripheral and Central Nervous System Advisory Committee. Teva, which markets MS drug Copaxone glatiramer acetate, said that "given the recent history of emerging, serious safety issues" for Tysabri natalizumab from Elan Corp. plc (NYSE:ELN, Dublin, Ireland) and ...

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