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As of Nov 14, 2026, ANDA 207754 (Fulvestrant), held by Glenmark Pharms, was first approved by FDA on Aug 22, 2019, with 0 approved supplements and 0 published complete response letters.
First approved: Aug 22, 2019
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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
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.
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
