You are here

Rimonabant NDA Withdrawn From FDA Consideration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

Recent Headlines

Averts Disease Worsening, Reduces Potential for Blindness
Risk May Remain for 6 Months After Treatment
FDA Removes Boxed Warning With Drug’s Fifth Approval
Overeager Use of Recommendations Creates Problems
Artificial Intelligence Enables Platform to Detect Amyloid PET Status
Kadcyla Cut Risk of Recurring Disease by Half Compared to Herceptin
May Lead to Personalized Treatment for Schizophrenia, Other Illnesses
First Medicines for Adults With Wild-type or Hereditary ATTR-CM