Diet Drug Acomplia May Be Available for Purchase in July in Britain or Germany

"Hanspeter Spek, executive vice president, pharmaceutical operations, Sanofi-Aventis, told financial analysts on May 5th that Sanofi is "very active in preparing for our first launches," which almost surely will take place in Europe and not the United States. A key committee of the European Medicines Agency (EMEA), the Committee for Medicinal Products for Human Use (CMPH), on April 28th recommended approval of Acomplia as an aid to weight-loss. More than 95 percent of CHMP recommendations lead to EMEA marketing authorizations in just over two months. "We are confident to launch in the first market then in the period July to August, and those markets traditionally in Europe are the United Kingdom and Germany," Spek said."

So SNY says that a European release is more likely to happen before a US release. I have a feeling the US won't be seeing any Accomplia sales this year.

FDA Approves New Smoking-Cessation Aid 10 Weeks After Rejecting Acomplia

"Ten weeks after rejecting Sanofi's application to market Acomplia (rimonabant) as a smoking-cessation aid, the U.S. Food and Drug Administration on May 11th approved the first new prescription drug for smoking cessation in nearly a decade. ] ... The FDA is believed to have informed Sanofi that it would have to conduct a new clinical trial of Acomplia before it would receive further consideration as a smoking cessation aid. Sanofi has not said whether it intends to conduct such a trial."

Although not a major blow, this still hurts SNY. It was designed as a drug that could address both obesity and smoking - and now they are only allowed to talk about obesity. Looks like the FDA is continuing to drag it's heels over Accomplia. I wonder why? News Source