It seems FDA isn't as comfortable as some thought about letting Sanofi-Aventis ' much-vaunted obesity candidate rimonabant (Acomplia) onto the market. The agency in February issued an approvable letter for the first-in-class cannabinoid-1 receptor antagonist in weight management—meaning further information is required--and a not approvable in smoking cessation, which is basically a "No."
Sanofi's Acomplia Stumbles
It seems FDA isn't as comfortable as some thought about letting Sanofi-Aventis' much-vaunted obesity candidate rimonabant (Acomplia) onto the market. But the agency's caution--and that's all it appears to be--isn't so surprising.