Iterum Therapeutics expands ORLYNVAH distribution through McKesson

Iterum Therapeutics plc (NASDAQ: ITRM) announced that its antibiotic ORLYNVAH is now available through McKesson's specialty distribution channel, allowing physicians to procure the product directly from the distributor.

The Dublin-based company also received 510(k) clearance from the U.S. Food and Drug Administration for its 2 µg Antimicrobial Susceptibility Test Disc. The disc, manufactured by Liofilchem, is designed for use in microbiology laboratories to test bacterial susceptibility to sulopenem using the disc diffusion method.

The FDA-cleared disc helps determine susceptibility of Enterobacterales bacteria to sulopenem and supports antimicrobial stewardship efforts. Liofilchem received authorization from FDA's Global Unique Device Identification Database to commercialize the sulopenem susceptibility disc in the United States.

ORLYNVAH is an oral penem antibiotic approved for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited alternative oral treatment options. The drug demonstrates activity against bacteria resistant to other antibiotics, including those with ESBL or AmpC-type ß-lactamases that resist third-generation cephalosporins.

Iterum focuses on developing anti-infectives to combat multi-drug resistant pathogens. The company's lead compound sulopenem has both oral and intravenous formulations and has received Qualified Infectious Disease Product and Fast Track designations from the FDA for seven indications.

The information is based on a company press release statement.

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