For type 2 diabetes mellitus. NDA 209803, held by Msd Sub Merck. Ertugliflozin.
As of Nov 13, 2026, NDA 209803 (Steglatro), held by Msd Sub Merck, was first approved by FDA on Dec 19, 2017, with 7 approved supplements and 0 published complete response letters.
STEGLATRO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Sep 17, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Steglatro5MG · tablet;oral | Ertugliflozin | RxReference drug |
| Steglatro15MG · tablet;oral | Ertugliflozin | RxReference drug |
| Jun 3, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Dec 20, 2024 | Supplement 8Labeling · Standard review | Approved | |
| Sep 12, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Oct 13, 2022 | Supplement 6Labeling | Approved | |
| Sep 17, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2020 | Supplement 2Labeling | Approved | |
| Oct 26, 2018 | Supplement 1Labeling | Approved | |
| Dec 19, 2017 | Original applicationNew molecular entity · 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
