French pharmaceutical group Sanofi-Aventis said Friday it had withdrawn an application for regulatory approval for its anti-obesity drug Acomplia in the United States.
A panel of experts from the US Food and Drug Administration concluded earlier this month that the dieting treatment, referred to as rimonabant by the company, was unsafe and should not be sold in the United States."Sanofi-Aventis will work towards submitting the rimonabant file to the FDA at a future date," the company said, adding that it will "undertake the necessary discussions with the FDA to determine the required modifications to its file."
The FDA's expert panel concluded that suicidal thoughts appeared to be a side-effect of taking Acomplia, which has been authorised in the European Union.
The FDA was expected to heed the opinion of the panel of experts and block the sale of the drug.
Sanofi had previously forecast annual sales of 3.0 billion euros (4.0 billion dollars) for the drug.
In a separate development, European regulators said they were reviewing data on the psychiatric effects of Acomplia.
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The agency "is currently reviewing the available data on psychiatric events (in particular suicidal ideation and depression-related events)," it said.
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Source-AFP
MED
