Treats hormone receptor (HR)-positive, human epidermal growth factor receptor 2…. NDA 208716, held by Eli Lilly And Co. Abemaciclib.
As of Nov 13, 2026, NDA 208716 (Verzenio), held by Eli Lilly And Co, was first approved by FDA on Sep 28, 2017, with 12 approved supplements and 0 published complete response letters.
VERZENIO is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer. in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
| Sep 18, 2026 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jul 13, 2026 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Nov 13, 2024 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2017 | Original applicationNew molecular entity · Priority review | Approved |
| Verzenio50MG · tablet;oral | Abemaciclib | RxReference drug |
| Verzenio100MG · tablet;oral | Abemaciclib | RxReference drug |
| Verzenio150MG · tablet;oral | Abemaciclib | RxReference drug |
| Verzenio200MG · tablet;oral | Abemaciclib | RxReference drug |
| Sep 18, 2026 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jul 13, 2026 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2025 | Supplement 19Labeling · Standard review | Approved | |
| Nov 13, 2024 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 2020 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2019 | Supplement 3Labeling | Approved | |
| Aug 17, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Sep 28, 2017 | Original applicationNew molecular entity · Priority review | Approved |
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
