Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 202602, held by Zydus Pharms. Exemestane.
As of Nov 13, 2026, ANDA 202602 (Exemestane), held by Zydus Pharms, was first approved by FDA on Oct 3, 2018, with 2 approved supplements 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. the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jun 10, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 8, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 3, 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
