Treats uncomplicated urinary tract infections (uUTI) caused by the designated…. NDA 213972, held by Iterum Therap. Probenecid; Sulopenem Etzadroxil.
As of Nov 13, 2026, NDA 213972 (Orlynvah), held by Iterum Therap, was first approved by FDA on Oct 25, 2024, with 2 approved supplements and 1 published complete response letter.
ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Limitations of Use ORLYNVAH is not indicated for the treatment of: Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. ( 1.1, 14.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 25, 2024 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 23, 2021 | Sulopenem etzadroxil and probenecidContainer Labels And Carton Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orlynvah500MG;500MG · tablet;oral | Probenecid; Sulopenem Etzadroxil | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Mar 24, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Oct 25, 2024 | Original applicationNew molecular entity, new combination · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
