For endocrine therapy. ANDA 209246, held by Dr Reddys. Fulvestrant.
As of Nov 14, 2026, ANDA 209246 (Fulvestrant), held by Dr Reddys, was first approved by FDA on Aug 7, 2020, with 0 approved supplements and 0 published complete response letters.
Monotherapy Fulvestrant 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 Combination Therapy Fulvestrant 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. HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 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
