For type 1 diabetes mellitus. BLA 205692, held by Eli Lilly And Co. Insulin Glargine.
As of Nov 14, 2026, BLA 205692 (Basaglar), held by Eli Lilly And Co, was first approved by FDA on Dec 16, 2015, with 8 approved supplements and 0 published complete response letters.
BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Basaglar300 UNITS/3ML (100 UNITS/ML) · solution;subcutaneous | Insulin Glargine | Rx |
| Jul 20, 2021 | Supplement 33Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 25Labeling | Approved | |
| Nov 15, 2019 | Supplement 24Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 21Labeling · Standard review | Approved | |
| Sep 5, 2018 | Supplement 19Labeling · Standard review | Approved | |
| Jun 17, 2016 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 17, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Jun 1, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Dec 16, 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
