Treats complicated urinary tract infections (cUTI) including pyelonephritis caused by…. NDA 209776, held by Rempex. Meropenem; Vaborbactam.
As of Nov 14, 2026, NDA 209776 (Vabomere), held by Rempex, was first approved by FDA on Aug 29, 2017, with 5 approved supplements and 0 published complete response letters.
VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2017 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vabomere1GM/VIAL;1GM/VIAL · powder;intravenous | Meropenem; Vaborbactam | RxReference drug |
| Feb 20, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Dec 3, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Sep 21, 2023 | Supplement 4Labeling · Standard review | Approved | |
| May 25, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Jul 6, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Aug 29, 2017 | Original applicationNew molecular entity, new combination · Priority 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
