Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 209208, held by Upsher Smith Labs. Exemestane.
As of Nov 13, 2026, ANDA 209208 (Exemestane), held by Upsher Smith Labs, was first approved by FDA on Jul 26, 2017, with 3 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 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 |
|---|---|---|---|
| Jul 26, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jun 16, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 27, 2022 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 22, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 26, 2017 | 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
