Cytoxan Not Withdrawn Over Safety/Efficacy

Federal Register notice: FDA has determined that the sterile dry powder excipient-free formulation of Baxter Pharmaceuticals’ Cytoxan (cyclophosphamide) for injection, and the sterile dry powder with sodium chloride formulation of Cytoxan (cyclophosphamide) for injection, were not withdrawn for safety or effectiveness reasons. The determination means that FDA can continue to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. Cytoxan is indicated for treating malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma, multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, breast carcinoma, and minimal change nephrotic syndrome in pediatric patients. To view the notice, click here.