News » October 2006

Sanofi’s Acomplia expects oct 31’06 as the D-day for FDA-approval

October 25, 2006

French pharmaceutical giant Sanofi-Aventis’s brush with the D-day may soon be knocking at the door. As Sanofi's top brass plan to meet on October 31, 2006 with the financial analysts to report on the company's third quarter earnings, it is believed to be the initial brush with truth as the analyst get ready to be grilled by the U.S. Food and Drug Administration on its highly anticipated diet pill and anti-smoking drug Rimonabant (brand: Acomplia/Zimulti)

The meet is said to be significant because at analogous sessions earlier this year, analysts largely permitted Sanofi to evade questions about FDA’s delaying action on Acomplia, and generated expectations that approval of Rimonabant for sale in the United States was expected before the end of the year. But tension seems to build up with the passage of time since there has been no response from the FDA. Many term this silence as a call for an enduring problem with Acomplia’s approval by FDA.

The falling stock prices of Sanofi in the recent months can in many ways be related to the pending approval of Acomplia. This has of late spurred the rumor mills to make predictions of a delay in approval until the first quarter of 2007 and even later. But Sanofi officials are quite optimistic and see these predictions as mere speculations.

As Sanofi-Aventis manages to grab the world’s attention for its D-day on Oct 31’06, by propagating its outstanding performance in the United Kingdom, since its business in the country since June this year, but time will say if Acomplia gets is due with the FDA approval for initiating sales in the United States.