For type 2 diabetes mellitus. BLA 208673, held by Sanofi-Aventis US. Insulin Glargine; Lixisenatide.
As of Nov 14, 2026, BLA 208673 (Soliqua 100/33), held by Sanofi-Aventis US, was first approved by FDA on Nov 21, 2016, with 11 approved supplements and 0 published complete response letters.
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Feb 27, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2016 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Soliqua 100/33300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) · solution;subcutaneous | Insulin Glargine; Lixisenatide | Rx |
| Mar 12, 2026 | Supplement 23Labeling · Standard review | Approved | |
| May 28, 2025 | Supplement 18Labeling · Standard review | Approved | |
| Nov 1, 2024 | Supplement 14Labeling | Approved | |
| Sep 28, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Jun 10, 2022 | Supplement 12Labeling | Approved | |
| Jul 28, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 9Labeling | Approved | |
| Nov 15, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Feb 27, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2017 | Supplement 3Manufacturing | Approved | None posted |
| Aug 29, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Nov 21, 2016 | Original applicationNew combination · 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
