For endocrine therapy. NDA 210326, held by Fresenius Kabi USA. Fulvestrant.
As of Nov 13, 2026, NDA 210326 (Fulvestrant), held by Fresenius Kabi USA, was first approved by FDA on May 20, 2019, with 2 approved supplements and 0 published complete response letters.
Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fulvestrant250MG/5ML (50MG/ML) · solution;intramuscular | Fulvestrant | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 12, 2021 | Supplement 2Labeling · Standard review | Approved | |
| May 20, 2019 | Original applicationNew formulation or manufacturer · Standard review | 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
