BOEHRINGER INGELHEIM — Jentadueto Xr FDA Summary Review (NDA/BLA 208026, 2017)
Boehringer Ingelheim · 2017 · FDA Summary Review (Drugs@FDA)
Report summary
Boehringer Ingelheim's New Drug Application for Jentadueto XR (linagliptin/metformin extended-release) for type 2 diabetes is recommended for approval by the FDA. This fixed-dose combination leverages the established safety and efficacy of its individual components, linagliptin (Tradjenta) and metformin extended-release (Glumetza), both previously approved. Bioequivalence studies confirmed that Jentadueto XR is comparable to co-administering the separate drugs. The FDA found no new safety or efficacy concerns, supporting its approval.
Key findings — cited to the page
| Recommendation for approval | Approval | Jentadueto XR · p.9 |
| NDA number | 201280 | · p.11 |
| NDA number | 201281 | · p.11 |
| NDA number | 208026 | Jentadueto XR · p.3 |
| Regulatory pathway | 505(b)(1) | Jentadueto XR · p.3 |
| Proposed indication | adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate | Jentadueto XR · p.3 |
| Linagliptin NDA number | 201280 | Tradjenta · p.3 |
| Metformin extended-release NDA number | 021748 | Glumetza · p.3 |
| Linagliptin dosage | 5 mg once daily | Linagliptin · p.3 |
| Metformin XR starting dose | 1000 mg once daily | GLUMETZA · p.3 |
| Metformin XR maximum dose | 2000 mg | GLUMETZA · p.3 |
Source: Boehringer Ingelheim ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →