The FDA have issued Sanofi-Aventis with an "approvable letter" for its weight-loss drug Acomplia, marking a preliminary step toward possible final approval, the French pharmaceutical company said Friday.
The company did not disclose the contents of the letter but said it would continue to work in "close collaboration" with the FDA. Generally, approvable letters sketch out additional conditions that must be met before final approval.
Sanofi-Aventis added that the FDA also issued a "non-approvable letter" for use of the drug, (aka rimonabant), as a stop-smoking aid.
Insider cant wait for the launch party.
Source:AP
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