For endocrine therapy. ANDA 211689, held by Accord Hlthcare. Fulvestrant.
As of Nov 14, 2026, ANDA 211689 (Fulvestrant), held by Accord Hlthcare, was first approved by FDA on Nov 17, 2020, with 1 approved supplement and 0 published complete response letters.
Monotherapy Fulvestrant injection is 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, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy Fulvestrant injection is indicated for the treatment of: 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 |
|---|---|---|---|
| Nov 17, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fulvestrant250MG/5ML (50MG/ML) · solution;intramuscular | Fulvestrant | Rx |
| Oct 23, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 17, 2020 | 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
