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FDA orders Abbott to withdraw obesity drug

October 8, 2010 11:34 PM UTC

FDA ordered Abbott Laboratories (NYSE:ABT) to withdraw obesity drug Meridia sibutramine in the U.S. The agency said Meridia's availability is not justified when comparing the "very modest weight loss" that people achieve on the drug to their risk of heart attack or stroke. Data from the postmarketing SCOUT trial showed that Meridia was associated with a significantly higher rate of primary cardiovascular outcomes vs. placebo in overweight or obese patients with pre-existing cardiovascular disease and/or Type II diabetes. Last month, an FDA panel split 8-8 on whether to withdraw Meridia.

Abbott said it will also withdraw Meridia in Canada and Australia. It suspended sales in Europe in January. Global sales of Meridia for the first nine months of 2010 were about $80 million, including $20 million in the U.S. Abbott said the withdrawal will not affect its previously issued 3Q10 or 2010 EPS guidance. ...