Iterum Therapeutics gets FDA Advisory Committee meeting on Sept 9, 2024 for oral sulopenem NDA for uUTI

Iterum Therapeutics plc

FDA Advisory Committee to discuss NDA for oral sulopenem (first oral penem in U.S.) for uUTI in adult women; proposed date September 9, 2024.
Discussion topics: antimicrobial stewardship issues and appropriate target patient population.
PDUFA action date set at October 25, 2024 for Class II resubmission.

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