February 20, 2006 WASHINGTON (AP) -- Federal regulators issued Sanofi-Aventis 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 Food and Drug Administration. Generally, approvable letters sketch out additional conditions that must be met before the FDA can approve a drug.
Sanofi-Aventis added that the FDA also issued a non-approvable letter for use of the drug, formally known as rimonabant, as a stop-smoking aid.
FDA spokeswoman Kathleen Quinn confirmed the two letters were sent Friday.
The drug acts by blocking the same pleasure centers in the body activated when pot smokers get the munchies. People taking the drug eat less.
Research has shown that the drug also helps people quit smoking. The company did not immediately disclose why the FDA apparently would not approve the drug for that use.
Copyright 2006 The Associated Press. All rights reserved.
