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News From the Food and Drug Administration
April 7, 2015

New Antibacterial Drug Approved

Author Affiliations

Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;313(13):1306. doi:10.1001/jama.2015.2800

The fifth antibacterial drug designated as a qualified infectious disease product has received US Food and Drug Administration (FDA) approval. Such drugs treat serious or life-threatening infections. The agency expedites its review of these products and doubles their marketing exclusivity period from 5 years to 10 years.

Avycaz combines ceftazidime, a cephalosporin antibacterial drug that was already on the market, and avibactam, a new β-lactamase inhibitor. It will be marketed to treat 2 complicated infections in adults: intra-abdominal infections, administered in combination with metronidazole, and urinary tract infections, including kidney infections.

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