Iterum Therapeutics receives 510(k) clearance for Susceptibility Test Disc

Iterum Therapeutics (ITRM) provided a business update. Specialty Distributor Now Stocked: ORLYNVAH is now available at McKesson, which will allow certain physicians the ability to procure the product directly from McKesson through this specialty distribution channel, consistent with their practice preferences. Sulopenem Susceptibility Disc FDA Cleared & Now Available to Order: Iterum has received 510(k) clearance by the U.S. Food and Drug Administration of its 2 microgram Antimicrobial Susceptibility Test Disc. This disc, manufactured by Liofilchem, is intended for use in microbiology laboratories for susceptibility testing by the disc diffusion method to determine susceptibility of Enterobacterales to sulopenem, utilizing FDA Susceptibility Test Interpretive Criteria. Antimicrobial susceptibility testing helps guide clinicians to use effective and targeted therapies for individual patients and is a key component of antimicrobial stewardship, helping to combat the growing threat of antimicrobial resistance. Liofilchem has received authorization from FDA’s Global Unique Device Identification Database for the commercialization of the sulopenem susceptibility disc in the United States. For Microbiology Laboratories and Antimicrobial Stewardship Committees who are interested in sulopenem susceptibility testing, discs are now available and can be ordered at Liofilchem, Inc.