For diabetes mellitus. BLA 761109, held by Eli Lilly And Co. Insulin Lispro-Aabc.
As of Nov 13, 2026, BLA 761109 (Lyumjev), held by Eli Lilly And Co, was first approved by FDA on Jun 15, 2020, with 2 approved supplements and 0 published complete response letters.
LYUMJEV is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 2022 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 13, 2021 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lyumjev100UNITS/ML(U-100) · injectable;injection | Insulin Lispro-Aabc | Rx |
| Lyumjev200UNITS/ML(U-200) · injectable;injection | Insulin Lispro-Aabc | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
