Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 210323, held by Cipla. Exemestane.
As of Nov 13, 2026, ANDA 210323 (Exemestane), held by Cipla, was first approved by FDA on Apr 27, 2018, with 3 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 tablets, USP 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 27, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jul 1, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 15, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 22, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 27, 2018 | 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
