2007年6月29 日，赛诺菲撤回了在美国销售减肥药Zimulti的申请，而不是等待看来是不可避免的结果：FDA将驳回药品上市申请。
Zimulti的通用名为利莫那班，在欧洲的商品名为 Acomplia 。数周前FDA咨询委员会指出此药致精神病副作用。FDA通常情况下很看重该委员会的建议，因此预计6月份下旬FDA会宣布此药上市申请的审批结果。赛诺菲科学和医疗事务主管Marc Cluzel今天在媒体吹风会上说，公司会满足FDA（的要求）并且晚些时候会再提交此药的申请，而且对患者群的定位会更准确。据Thomson财政部门提供的笔录，他说道：“我们觉得肥胖患者本身没有好的体形，而有疾病表现的肥胖与肥胖症关系密切”。
附：新闻来源
June 29, 2007, 4:22 pm
Sanofi Retreats on Acomplia, Vows to Try Again
Posted by Jacob Goldstein
Rather than wait for a FDA rejection that had come to seem inevitable, Sanofi-Aventis today withdrew its application to sell its weight-loss drug Zimulti in the United States.
The drug, known generically as rimonabant and sold as Acomplia in Europe, was trounced a few weeks ago by an FDA advisory panel concerned by the drug’s psychiatric side effects.
The FDA, which usually follows the advice of its committees, was scheduled to rule on the drug by late July.
The company will meet with the FDA and re-submit the drug for approval at some point, possibly with a more targeted patient population in mind, Sanofi’s head of science and medical affairs Marc Cluzel said today on a conference call. “We really feel the good profile is … not the obese patient per se, but obese with morbid complications linked to obesity,” he said, according to a transcript provided by Thomson Financial.
