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Sanofi Drug Hits New Hurdle With Indian Knockoffs (India)

This article was originally published in PharmAsia News

Executive Summary

Cipla Ltd. and Ranbaxy Laboratories Ltd. are among six drugmakers exploiting a loophole in India patent laws, selling copies of Sanofi-Aventis SA's Acomplia weight-loss pill without prescription for as little as 12 cents. The knockoffs may end Acomplia's chances of being approved by the U.S. Food and Drug Administration. "This is going to be potentially disastrous,'' said Jeffrey Mechanik, an endocrinologist at Mt. Sinai Hospital in New York. "People are going to be over-dosing" if generics flood the market and people take them inappropriately, he said. Sanofi received approval to sell Acomplia in India in May, the same month as the generic-drug makers. The company has not decided whether to sell its branded version there. The Indian regulator approved rimonabant, or generic Acomplia, requiring patients get a prescription and medical advice on its risks. Those include depression and anxiety - side effects that were serious enough to prompt an FDA panel of advisers to recommend that FDA reject the pill. European regulators, who approved the medicine last year, tightened prescribing rules last month to say Acomplia should not be used by those taking antidepressants or who have depression. India is growing obese, with almost a third of women and more than a fifth of men living in urban areas considered overweight, according to a government survey last year. Obesity can lead to high blood pressure and diabetes, to which South Asians have a genetic predisposition. Unregulated use of the medicine could spell trouble for Sanofi, researchers say. "Doctors should be very careful because in all the clinical trials, there was a slight increase in anxiety and depression," said Andre Scheen, head of diabetes, nutrition and metabolic disorders at the University of Liege, Belgium, who led a clinical trial on Acomplia. (Click here for more - May Require Free Registration

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