Xacduro FDA Approval History
Last updated by Judith Stewart, BPharm on May 24, 2023.
FDA Approved: Yes (First approved May 23, 2023)
Brand name: Xacduro
Generic name: sulbactam and durlobactam (co-packaged)
Dosage form: Kit for Injection
Company: Innoviva Specialty Therapeutics
Treatment for: Acinetobacter Pneumonia
Xacduro (sulbactam and durlobactam) is a co-packaged product containing the beta-lactam antibacterial sulbactam, and the beta lactamase inhibitor durlobactam for use in the treatment of serious infections caused by Acinetobacter.
- Xacduro is indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
- Bacteria within the genus Acinetobacter (principally Acinetobacter baumannii-calcoaceticus complex) are pathogens that predominantly cause infections in critically ill hospitalized patients, often resulting in severe pneumonia and bloodstream infections.
- Xacduro contains sulbactam and durlobactam. Sulbactam works as an antibacterial due to inhibition of Acinetobacter baumannii-calcoaceticus (ABC) complex penicillin-binding proteins PBP1 and PBP3, which are essential enzymes required for bacterial cell wall synthesis. Durlobactam protects sulbactam from degradation by certain serine-beta-lactamases. Durlobactam alone does not have antibacterial activity against ABC isolates.
- Xacduro is administered by intravenous (IV) infusion over 3 hours.
- Warnings and precautions associated with Xacduro include serious hypersensitivity reactions and Clostridioides difficile-associated diarrhea.
- Common adverse reactions include liver test abnormalities, diarrhea, anemia, and hypokalemia.
Development timeline for Xacduro
Further information
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