Treats postmenopausal women with estrogen-receptor positive early breast cancer. ANDA 216454, held by Eugia Pharma. Exemestane.
As of Nov 13, 2026, ANDA 216454 (Exemestane), held by Eugia Pharma, was first approved by FDA on May 20, 2022, with 1 approved supplement 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 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 |
|---|---|---|---|
| May 20, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Exemestane25MG · tablet;oral | Exemestane | Rx |
| Jul 24, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 20, 2022 | 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
