For type 2 diabetes mellitus. ANDA 215245, held by Biocon Pharma. Liraglutide.
As of Nov 15, 2026, ANDA 215245 (Liraglutide), held by Biocon Pharma, was first approved by FDA on Mar 11, 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 |
|---|---|---|---|
| Mar 11, 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
