Thiotepa for injection is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. ( 1.1, 14 ) For treatment of adenocarcinoma of the breast or ovary. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. For treatment of superficial papillary carcinoma of the urinary bladder. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2020 | Original application | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 30, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 4, 2020 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
