Paclitaxel injection [NK] (PTX [NK]) is a generic of Taxol® Injection (Taxol) but no non-clinical study comparing the safety of the 2 drugs has been conducted because the active ingredient is the same.
We compared the safety of PTX [NK] and Taxol in rats to see if there were any differences. PTX [NK] and Taxol were intravenously administered to CD (SD) male rats at doses of 2.0 and 4.0 mg/kg/day for 9 days. There were very slight differences in toxicological findings regarding such items as clinical observations, food consumption, gross necropsy, organ weight and histopathology. These differences, however, were generally observed after administration of a cytocidal anticancer drug. Therefore, such differences were not thought to be toxicologically significant and we concluded that the safety of PTX [NK] was no different from that of Taxol in rats.
