Treats Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. NDA 210303, held by Cipla USA. Plazomicin Sulfate.
As of Nov 13, 2026, NDA 210303 (Zemdri), held by Cipla USA, was first approved by FDA on Jun 25, 2018, with 2 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZemdriEQ 500MG BASE/10ML (EQ 50MG BASE/ML) · solution;intravenous | Plazomicin Sulfate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Jul 15, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jun 25, 2018 | Original applicationNew molecular entity · 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
