FDA Panel Backs Looser Limits On GSK's Avandia

Law360, New York (June 6, 2013, 5:30 PM EDT) -- A U.S. Food and Drug Administration panel on Thursday recommended dialing back restrictions on GlaxoSmithKline PLC’s diabetes medicine Avandia after finding the risk of heart attacks had likely been overblown, but the move might be too late to restore the much-maligned drug’s reputation.

Half of the 26-member committee advised the FDA to modify so-called risk evaluation and mitigation strategies that allow use of Avandia, or rosiglitazone, only by certain patients and permit it to be prescribed and dispensed only by certified doctors and pharmacists.

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