Generic Rimonabant
is AVAILABLE NOW! click here

	FRANÇAIS DEUTSCH ITALIANO ESPAÑOL ENGLISH --- Select Language ---
	What is Acomplia® Acomplia by Sanofi Aventis Generic Acomplia (Rinomabant) Side Effects

Acomplia approval

Acomplia (Rimonabant), developed by Sanofi-Aventis. The first launch of Acomplia® will take place in the United Kingdom in July 2006 and will be followed by launches in Denmark, Ireland, Germany, Finland and Norway during the second half of 2006.

Acomplia and FDA

In the United States, Acomplia® is currently under review by the U.S. Food and Drug Administration (FDA) and is not yet commercially available.

The drug may enter the market in the United States in 2006 but only when FDA approval is received. However, as of February 2006 FDA approval in 2006 appears still unlikely. This is because in February 2006 the FDA told Sanofi-Aventis it would need further information on rimonabant before it would be approved for the U.S. market. Neither the FDA nor Sanofi-Aventis has revealed what this information is.

Acomplia and EC (European Commission)

On 21 June 2006, the European Commission approved the sale of rimonabant in the 25-member European Union. Sanofi announced that the first country in which Acomplia will be sold is the United Kingdom. Sales began in July, 2006. Sanofi also announced that it projects that the drug will be sold shortly thereafter in Denmark, Ireland, Germany, Finland and Norway. It is expected in Belgium and Sweden in 2007. Ordinary obesity will, according to official medical recommendations, not be enough to acquire the prescription in Sweden; there are additional requirements concerning abnormal blood lipid levels.

The EU's approval was not a blanket approval, nor did it approve Acomplia for non-obesity related problems such as smoking cessation, although off-label use of the drug is still possible. The approval is in combination with diet and exercise for the treatment of obese patients (BMI greater than or equal to 30), or overweight patients (BMI greater than 27) with associated risk factors, such as type 2 diabetes or dyslipidaemia.

Acomplia (Rimonabant) Benefits

Acomplia's primary benefit is to reduce appetite, and thus help those who use the drug lose weight. There is also hope that Acomplia will help the health of patients in other ways.

• First, there is evidence it helps with lipid levels (such as cholesterol) in the blood.
• Second, it may help with other metabolism-related health problems, as well as help smokers quite smoking.

While these benefits sound exciting, not only has the FDA not approved Acomplia, but the FDA has strongly suggested it has no intention of approving rimonabant as a drug to aid quitting smoking. While if Acomplia is approved it can generally be prescribed by doctors for any purpose, without FDA approval Sanofi-Aventis will be unable to market Acomplia as a smoking-cessation drug. It remains to be seen what the FDA's atittude toward approving Acomplia for more than simple weight loss will be.

FDA approval of Acomplia

"We do not feel at all discouraged," said Sanofi CEO Gérard Le Fur.

"We are extremely optimistic about obtaining (FDA approval) for rimonabant," Cluzal said. "This will come about sooner or later, and hopefully, in the course of this year."

Update Jun 14, 2007: The U.S. Food and Drug Administration panel voted unanimously not to approve Rimonabant for the sale in the U.S. which means that in July when the U.S. FDA’s official decision is released the medication will not be approved.