FDA To Reassess Avandia Risk After Revisited Study

Law360, New York (April 12, 2013, 6:01 PM EDT) -- The U.S. Food and Drug Administration announced Friday it would consider another regulatory review of GlaxoSmithKline PLC’s former blockbuster diabetes treatment Avandia, which is restricted over cardiovascular risks, following a re-examination of data from a previous trial for the drug.

According to the announcement, scheduled to be published Monday in the Federal Register, the FDA will convene a meeting in June with its endocrinologic and metabolic drugs advisory committee and its drug safety and risk management advisory committee in order to discuss the results of an...
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