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Acomplia Rimonabant
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| FDA approval for Rimonabant |
In spite of the formal approval granted by the U.S. FDA during
February 2006 for the obesity indication and non approval letter for
smoking cessation therapy use, the drug Rimonabant or Acomplia
could not enter the United States markets until 2006. As declared by
the producers of the drug Sanofi-Aventis, the comprehensive response
to the approval letter of the FDA was officially submitted by the
company on 26 of October 2006.
This generates either the class 1 – two month or class 2 – six month
review system. The specific contents of such reviewed compliance
have neither been revealed by the U. S. FDA nor by Sanofi-Aventis.
But anyway, the Endocrine and Metabolic Drugs Advisory Committee –
EMDAC of the U.S. FDA has stated that they would evaluate the
marketing application on 13th of June, 2007.
However, the European Commission approved Rimonabant - Acomplia on
the 21st day of June 2006, for its sales in the twenty five member
nations of the European Union. As declared by the company, the
United Kingdoms would be the very first country where sale of
Rimonabant-Acomplia would be launched precisely since July 2006. As
per the next projection of the company, the sale would take place in
Denmark, Ireland, Germany, Finland and Norway. It is likely to be
sold in Belgium and Sweden by the year 2007.
The FDA approval by the European Union to Rimonabant- Acomplia was
not the total approval as it never approved the drug for
applications in other than the anti-obesity treatment. However, the
off-record usage of Rimonabant including anti-smoking and
anti-alcohol or drugs additions is still possible. The formal
approval of the drug by the FDA signifies its use in combination
with recommended diet and exercise plans. |
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