Treats postmenopausal women with hormone receptor-positive … metastatic breast cancer. ANDA 212434, held by Eugia Pharma. Anastrozole.
As of Nov 15, 2026, ANDA 212434 (Anastrozole), held by Eugia Pharma, was first approved by FDA on Jul 24, 2020, with 1 approved supplement and 0 published complete response letters.
Anastrozole is an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Anastrozole1MG · tablet;oral | Anastrozole | Rx |
| Oct 24, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 24, 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
