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BioWorld - Saturday, March 14, 2026
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Home » FDA adcom debates efficacy of Entasis’ infection drug
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FDA adcom debates efficacy of Entasis’ infection drug

April 17, 2023
By Lee Landenberger
Despite concerns about a limited dataset to study, the urgent need to treat one of the toughest and most deadly infections propelled a U.S. FDA advisory committee to unanimously support the NDA for Entasis Therapeutics Inc.’s sulbactam-durlobactam (Sul-Dur). Sul-Dur, an injectable combination of beta-lactam antibiotic and beta-lactamase inhibitor for treating adults with hospital‐acquired bacterial pneumonia and ventilator‐associated bacterial pneumonia caused by susceptible strains of carbapenem-resistant Acinetobacter baumannii infections, has a May 29 PDUFA date.
BioWorld Regulatory Infection FDA

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