Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 213547, held by Qilu. Exemestane.
As of Nov 13, 2026, ANDA 213547 (Exemestane), held by Qilu, was first approved by FDA on Apr 13, 2020, with 2 approved supplements and 0 published complete response letters.
Exemestane is an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy. treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 13, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jul 24, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 24, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 13, 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
