FDA Loosens Restrictions On GSK's Avandia

Law360, New York (November 25, 2013, 5:16 PM EST) -- The U.S. Food and Drug Administration on Monday removed prescribing restrictions on GlaxoSmithKline PLC’s onetime blockbuster diabetes medication Avandia, capping a turnaround in the agency's assessment of its cardiovascular risks three years after nearly yanking market approval.

The FDA said it would allow the use of Avandia by all patients with Type 2 diabetes, not just those already taking it or who cannot be treated with any other medication. The agency will also drop so-called risk evaluation and mitigation strategies permitting it to be prescribed only by...
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