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French Heart Drug Rejected By FDA

Added September 8th, 2006

The Food and Drugs Administration has rejected a new French drug that was submitted for approval for treatment of patients with irregular heartbeats. The manufacturers of the drug had been hoping that the medication would be not only approved but would also be a real success and generate huge profits.

The manufacturer of the drug, which is called Multaq, is Sanofi Adventis. The company received a ‘non-approvable letter’ detailing the rejection of the drug by the Food and Drugs Administration.

Although no comment was given by the FDA with regards to reasons for rejection, it was stated that the non-approvable letter indicated that there was insufficient safety or efficacy proof in the application submitted by the manufacturer.

The company is still awaiting approval on the European application for approval of the drug. Officials from the company have expressed disappointment in the rejection but state that the application will be re-submitted once further clinical trials have been carried out.

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