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news.Sanofi-Aventis has said that US health authorities have extended the review of its weight loss drug Acomplia by three months.
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Sanofi said it had expected the decision by April 26. Last week an independent advisory committee in France endorsed the drug for reimbursement by health insurance companies and state social security plans. Sanofi plans to launch the drug in France in March.
However, in January 2007, the German Ministry of Health decided that Acomplia should not be available for reimbursement under the German compulsory health insurance scheme. Sanofi is currently challenging this decision and believes the classification is unjust given the drugs profile.
Acomplia has already been launched in the United Kingdom, Denmark, Germany Ireland, Norway, Austria, Argentina, Sweden and Greece.
Sanofi did not comment on the reasons behind the delay in approval of Acomplia in the US.