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ARTICLE | Clinical News

Antara fenofibrate regulatory update

May 9, 2011 7:00 AM UTC

FDA issued a new quarterly report on safety information emerging from its Adverse Events Reporting System (AERS) during 4Q10 in which the agency identified a "paradoxical" reduction in HDL cholesterol in patients receiving fenofibrate products. FDA is evaluating the reports to determine if regulatory action is needed. ...