For endocrine therapy. ANDA 211422, held by Chia Tai Tianqing. Fulvestrant.
As of Nov 14, 2026, ANDA 211422 (Fulvestrant), held by Chia Tai Tianqing, was first approved by FDA on Feb 7, 2020, with 0 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 |
|---|---|---|---|
| Feb 7, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fulvestrant250MG/5ML (50MG/ML) · solution;intramuscular | Fulvestrant | Rx |
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
