FDA日前批准首个依诺肝素钠注射剂仿制药用于预防深度静脉血栓形成。依诺肝素钠注射剂于1993年获批,依诺肝素钠由肝素制成,其活性成分是一种天然衍生的复杂糖分子。为使仿制药获得FDA批准,制造商必须证明仿制药含有品牌药物系统的活性组分。对于像依诺肝素钠这样的天然产物,这 FDA recently approved the first generic version of enoxaparin sodium for preventing deep venous thrombosis. Enoxaparin sodium injection was approved in 1993, enoxaparin sodium is made of heparin, the active ingredient is a naturally derived complex sugar molecule. To obtain generic FDA approval, manufacturers must demonstrate that the generic drug contains the active ingredients of the branded drug system. For natural products like enoxaparin sodium, this is