For type 2 diabetes mellitus. ANDA 218115, held by Emerge Bioscience. Liraglutide.
As of Nov 15, 2026, ANDA 218115 (Liraglutide), held by Emerge Bioscience, was first approved by FDA on Apr 2, 2025, with 1 approved supplement and 0 published complete response letters.
Liraglutide Injection is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use: Liraglutide Injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liraglutide18MG/3ML (6MG/ML) · solution;subcutaneous | Liraglutide | Rx |
| Oct 15, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 2, 2025 | Original application | Approved | None posted |
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
