For type 2 diabetes mellitus. ANDA 217590, held by Orbicular. Liraglutide.
As of Nov 15, 2026, ANDA 217590 (Liraglutide), held by Orbicular, was first approved by FDA on Jan 14, 2026, with 0 approved supplements 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. to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use: Liraglutide injection contains liraglutide. Coadministration with other liraglutide-containing products is not recommended.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Liraglutide18MG/3ML (6MG/ML) · solution;subcutaneous | Liraglutide | Rx |
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
