NDA 208855, held by Eli Lilly And Co. Abemaciclib.
As of Nov 14, 2026, NDA 208855 (Verzenio), held by Eli Lilly And Co, was first approved by FDA on Feb 26, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2018 | Original applicationNew indication · Priority review | Approved |
| Verzenio50MG · tablet;oral | Abemaciclib | Rx |
| Verzenio100MG · tablet;oral | Abemaciclib | Rx |
| Verzenio150MG · tablet;oral | Abemaciclib | Rx |
| Verzenio200MG · tablet;oral | Abemaciclib | Rx |
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
