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FDA Medication Tracker

← All approvals · Infections & vaccines · 2024

Orlynvah (sulopenem etzadroxil, probenecid)

The FDA approved Orlynvah (sulopenem etzadroxil, probenecid) on October 25, 2024 to treat uncomplicated urinary tract infections (uUTI).
Brand name
Orlynvah
Generic name
sulopenem etzadroxil, probenecid
FDA approval date
October 25, 2024
Approved use (FDA wording)
To treat uncomplicated urinary tract infections (uUTI)
Company
Iterum Therap
Application
NDA213972
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

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. ( 1.1 ) 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 , 14.2 ) Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous anti…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.