For type 2 diabetes mellitus. BLA 761408, held by Eli Lilly And Co. Insulin Efsitora Alfa-Gobe.
As of Nov 13, 2026, BLA 761408 (Onswik), held by Eli Lilly And Co, was first approved by FDA on Sep 23, 2026, with 0 approved supplements and 0 published complete response letters.
ONSWIK is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2026 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onswik500 UNITS/ML · injectable;subcutaneous | Insulin Efsitora Alfa-Gobe | Rx |
| Onswik1000 UNITS/ML · injectable;subcutaneous | Insulin Efsitora Alfa-Gobe | 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
