NDA 212819, held by Msd Merck Co. Cilastatin Sodium; Imipenem; Relebactam.
As of Nov 13, 2026, NDA 212819 (Recarbrio), held by Msd Merck Co, was first approved by FDA on Jul 16, 2019, with 2 approved supplements and 0 published complete response letters.
RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options.
| Dec 9, 2025 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jun 4, 2020 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jul 16, 2019 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RecarbrioEQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL · powder;intravenous | Cilastatin Sodium; Imipenem; Relebactam | DiscontinuedReference drug |
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
