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FDA Accepts Sanofi-Aventis' Application for Rimonabant


Posted on 2006-12-08 09:38:00



Sanofi-aventis announces that concerning the New Drug Application for rimonabant in the United States, the Food and Drug Administration has considered its October 26, 2006 resubmission to be a complete, class 2 response to the FDA February 17, 2006 action letter.

The user fee goal date is April 26, 2007.

Rimonabant is a first-in-class cannabinoid type 1 (CB1) receptor blocker discovered and developed by sanofi-aventis.

In Europe, rimonabant, known as ACOMPLIA is approved as an adjunct to diet and exercise for the treatment of obese patients (BMI greater than or equal to 30kg/m2), or overweight patients (BMI>27kg/m2) with associated risk factors, such as type 2 diabetes or dyslipidaemia.

Rimonabant is currently commercialized in the United Kingdom, Germany, Denmark, Sweden, Finland, Norway, Ireland, Argentina and Austria.