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Rimonabant NDA Withdrawn From FDA Consideration

BRIDGEWATER, N.J., June 29 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today its decision to withdraw the rimonabant NDA - New Drug Application - in the United States.

Sanofi-aventis is confident in the positive benefit risk ratio of rimonabant 20mg when used in the appropriate population.

Sanofi-aventis will work toward submitting the rimonabant file to the FDA - Food and Drug Administration - at a future date. It will undertake the necessary discussions with the FDA to determine the required modifications to its file.

Sanofi-aventis is committed to taking all steps necessary to make rimonabant available to patients in the US market.

Rimonabant is a first in class therapy, discovered and developed by sanofi-aventis, is currently approved in 42 countries and marketed in 20 to treat obesity and overweight patients with associated cardiovascular risk factors.

Source: Sanofi-aventis

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