Wednesday, February 10, 2010
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FDA delays Botox approval for stroke-related muscle damage

(Reuters) UPDATED 2009-05-26
The U.S. Food and Drug Administration (FDA) has decided to delay its approval of the wrinkle med Botox for the treatment of upper limb muscle spasticity in stroke victims. FDA officials said the agency must first review the company's proposed Risk Evaluation and Mitigation Strategy for the medicine before approving it for the movement disorder.  The agency also has asked for additional information on one of the Botox clinical studies included in the approval application. Allergan, which makes Botox, said it believes it can satisfy those conditions in about 60 to 90 days.  Read full story >
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