Sanofi-Aventis' Acomplia (rimonabant) is "approvable" for weight loss but "not approvable" for smoking cessation, the company said Feb. 17.

The company submitted separate NDAs for Acomplia's two indications in April.

The firm said it "would continue to work in close collaboration with the FDA."

The applications were sent to two separate divisions within FDA's Office of New Drugs: the Division of Metabolic & Endocrine Drug Products reviewed the weight loss indication and the smoking cessation indication was evaluated by the Division of Anesthetic, Critical Care & Addiction Drug Products (¹ Also see "Acomplia Indications To Be Reviewed By Separate FDA Divisions, Sanofi Says" - Pink Sheet, 13 May, 2005.).

In August 2004, Sanofi said that it was planning to price Acomplia based on a statin pricing model, close to a $3-a-day range, and that pricing would reflect final labeling (² Also see "Acomplia Pricing Likely To Follow Statin Model, Sanofi Says" - Pink Sheet, 31 August, 2004.).

Sanofi said in May 2005 that it would add roughly 500 U.S. sales reps in anticipation of the Acomplia launch.

-Kathryn Phelps

Acomplia Is "Not Approvable" For Smoking Cessation, "Approvable" For Weight Loss

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