Probenecid; Sulopenem Etzadroxil

Treats uncomplicated urinary tract infections (uUTI) caused by the designated…. Sold as Orlynvah. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Probenecid; Sulopenem Etzadroxil (sold as Orlynvah), first approved Oct 25, 2024, with 0 new uses approved and 1 published complete response letter.

First approved: Oct 25, 2024
Applications: 1
New uses approved: 0
Complete response letters: 1

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in AdolescentsPharmacokinetics After Oral Intake · Iterum Therapeutics, International Limited	Phase 1	Recruiting	Jul 30, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 25, 2024	OrlynvahNDA 213972 · New molecular entity, new combination	Iterum Therap	2	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jul 23, 2021	Sulopenem etzadroxil and probenecidContainer Labels And Carton Labeling	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA