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Food and Drug Administration for approval are Sanofi-Aventis's Acomplia and Regeneron's Axokine. Sanofi submitted a New Biologic Application to the FDA, which in about-face issued a non approvable letter for Acomplia for use in smoker cessation. 3 kg (just over half a pound) on Acomplia 20 mg vs. And change in normalized total atheroma volume (TAV) decreased in the Acomplia group but increased in the placebo group. Nobody's going to touch this drug without long-term safety results," said Crawford, adding that he would need to see at least five years worth of safety data before considering prescribing Acomplia. Food and Drug Administration has not approved Acomplia because of its psychiatric side effects.

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