For type 2 diabetes mellitus. NDA 216743, held by Zydus Lifesciences. Metformin Hydrochloride; Sitagliptin.
As of Nov 14, 2026, NDA 216743 (Zituvimet), held by Zydus Lifesciences, was first approved by FDA on Nov 3, 2023, with 2 approved supplements and 0 published complete response letters.
ZITUVIMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET has not been studied in patients with a history of pancreatitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Zituvimet500MG;50MG · tablet;oral | Metformin Hydrochloride; Sitagliptin | RxReference drug |
| Zituvimet1GM;50MG · tablet;oral | Metformin Hydrochloride; Sitagliptin | RxReference drug |
| Aug 11, 2026 | Supplement 6Labeling | Approved | |
| May 29, 2025 | Supplement 5Manufacturing | Approved | |
| Nov 3, 2023 | Original applicationNew formulation or manufacturer · 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
