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MOUNTAIN VIEW, Calif.
Vivus Inc. said Tuesday that it now expects European Union regulators to make a decision on its obesity drug Qnexa no sooner than September.
Vivus said it will meet with a regulatory panel in Europe in September, and the European Medicines Agency will make a ruling on Qnexa sometime after that meeting. The panel asked Vivus about a meeting earlier this year, and the company said it needed extra time to prepare.
Vivus previously said it expected the agency to make a decision on Qnexa in the second quarter.
In the first quarter, the agency asked Vivus to provide more information on how it would minimize the risk of Qnexa's side effects, which include elevated heart rate, psychiatric problems and birth defects. Regulators also asked the company to discuss the benefits and risks of different doses of Qnexa, its possible use in different groups of patients, and the expected long-term benefits of treatment with Qnexa.
A Food and Drug Administration committee recommended approval for Qnexa in February. The FDA is scheduled to make a decision by July 17.
Shares of Vivus lost 19 cents to $23.49 in morning trading.