European Regulators Reject Vivus Obesity Drug Used In US

Law360, New York (October 19, 2012, 4:43 PM EDT) -- The European Medicines Agency on Thursday rejected Vivus Inc.’s application for approval of its Qsiva weight-control drug for human use, citing concerns about the drug’s long-term effects on patients’ heart and blood vessels, as well as their psychiatric and cognitive health.

Qsiva, a combination of weight-loss drug phentermine and seizure and migraine drug topiramate, was approved by the U.S. Food and Drug Administration in July and was recently launched in the U.S. under the trade name Qsymia.

The EMA’s Committee for Medicinal Products for Human Use...
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