Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC. Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 19, 2018 | Original application | Approved | None posted |
| Sep 19, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 19, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 19, 2018 | Original application | Approved | None posted |
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
