Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 211031, held by Breckenridge. Exemestane.
As of Nov 13, 2026, ANDA 211031 (Exemestane), held by Breckenridge, was first approved by FDA on Feb 21, 2019, with 1 approved supplement and 0 published complete response letters.
Exemestane tablets are 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 tablets 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 |
|---|---|---|---|
| Feb 21, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jun 15, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 21, 2019 | 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
