Novartis’ Sandoz gets FDA approval for intravenous Cyclophosphamide Injection

In a letter to Sandoz’s Gregory Seitz, Executive Director, Regulatory Affairs, the FDA stated: “Please refer to your new drug application dated and received August 12, 2022, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Cyclophosphamide Injection for intravenous use. We acknowledge receipt of your major amendment dated June 5, 2023, which extended the goal date by three months. This NDA provides for the use of Cyclophosphamide Injection for the treatment of adult patients with malignant lymphomas: Hodgkin’s lymphoma, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling.”