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Vivus公司最近再次向美国FDA递交了减肥复方产品Qnexa(芬特明+托吡酯)的新药申请(NDA),并缩小了其应用范围,即仅用于肥胖的男性和无生育能力的女性。此前由于本品中活性成分托吡酯可能导致新生儿先天缺陷(包括唇裂),本品未获FDA批准。此次为配合FDA的审批,应FDA要求,该公司正在开展一项名为FORTRESS的回顾性考察研究,旨在评价孕妇服用托吡酯后可能引起新生儿严重先天畸形和唇裂的风险,其结果有望于2012年3季度公布。
Vivus recently filed a new drug application (NDA) with the US FDA for Qnexa, a patented slimming compound, and has narrowed its scope of application to include only obese and non-fertile women. Prior to this product because of the active ingredient topiramate may cause birth defects in infants (including cleft lip), FDA has not been approved. In response to the FDA’s approval, the FDA is conducting a retrospective study entitled FORTRESS to assess the risk of pregnant women suffering from severe congenital anomalies and cleft lip after taking topiramate, the results expected to Third quarter of 2012 announced.