For diabetes mellitus. BLA 205747, held by Eli Lilly And Co. Insulin Lispro Recombinant.
As of Nov 13, 2026, BLA 205747 (Humalog Kwikpen), held by Eli Lilly And Co, was first approved by FDA on May 26, 2015, with 11 approved supplements and 0 published complete response letters.
HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Humalog Kwikpen200 UNITS/ML · solution;subcutaneous | Insulin Lispro Recombinant | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2025 | Supplement 38Labeling · Standard review | Approved | |
| Jul 21, 2023 | Supplement 28Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 22Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 25Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 26Labeling | Approved | |
| Aug 13, 2019 | Supplement 21Labeling · Standard review | Approved | |
| Nov 1, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Jun 6, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 25, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 26, 2015 | Original applicationNew formulation or manufacturer · Standard 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
