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FDA Slaps Genzyme With Refuse to File for Lemtrada

By Catherine Shaffer
Staff Writer

Monday, August 27, 2012

The FDA surprised Genzyme Corp., a Sanofi company, with a refuse to file letter for its supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis (MS).

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