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On February 17, 2006, the Food & Drug Administration (FDA) approved reduced liver monitoring for TASMAR® (tolcapone). Why did the FDA allow this change?

April 26, 2017Administration Approved drug fda food liver monitoring reduced

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On February 17, 2006, the Food & Drug Administration (FDA) approved reduced liver monitoring for TASMAR® (tolcapone). Why did the FDA allow this change?

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In May 2005, Valeant Pharmaceuticals submitted a supplemental new drug application for TASMAR that included updated safety data and proposed language for reduced liver monitoring requirements.