Zdrowie i gospodarka · 13/07/2012

FDA Clears Path for Topotecan Hydrochloride Approval via Abbreviated New Drug Applications

The FDA has determined that TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This decision will enable the FDA to approve abbreviated new drug applications (ANDAs) for topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, provided all other legal and regulatory requirements are fulfilled.