美国FDA批准新药数量依然在低谷徘徊,统计数据显示,2007年批准上市的新药仅有19个(表1),其中化学药物17个,生物制品2个,继1983年的14个和2002年的17个之后新药获批数量再陷低迷。表1 2007年美国FDA批准的新药和生物制品药物名称制药公司适应证作用方式获准日期二甲磺酸利右旋苯 The U.S. FDA approved the number of new drugs still hovering at a low level. Statistics show that there were only 19 new drugs approved for listing in 2007 (Table 1), including 17 chemical drugs and 2 biological products. Following 14 and 1983 of 1983 After 17 approved the number of new drugs subsided. Table 1 New Drugs and Biologicals Approved by the U.S. FDA in 2007 Name of Drug Pharmaceutical Company Indications Mode of action Date of approval Dideoxybenzene dimethanesulfonate