August 01, 2017
Clinigen Healthcare Ltd. is coordinating with US Food and Drug Administration (FDA) to temporarily import Cardioxane 500-mg powder for solution for infusion (dexrazoxane hydrochloride) 1 vial (NDC 76310-002-01) to help ease a critical shortage of dexrazoxane for injection 250-mg and 500-mg vials in the United States.
Cardioxane is licensed for sale in the United Kingdom and is manufactured by Cenexi-Laboratoires Thissen SA in Belgium.
Clinigen Healthcare is also offering Totect (dexrazoxane) for injection, 1 vial (500 mg, NDC 66220-110-01).
Clinigen Healthcare’s distributor for Cardioxane in the United States, Cumberland Pharmaceuticals Inc., is currently taking orders for both Cardioxane and Totect. Totect is expected to available to ship July 25, 2017, and Cardioxane, on July 28, 2017.
Dexrazoxane injection is used to prevent or treat side effects caused by chemotherapy medications. Both a cardioprotectant and a chemoprotectant, it stops chemotherapy drugs from damaging the heart and tissues.