Drug Information Update - FDA approves new antibacterial drug Zerbaxa

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The U.S. Food and Drug Administration approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI.

Zerbaxa is the fourth new antibacterial drug approved by the FDA this year. The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.

Zerbaxa is the fourth new antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Zerbaxa was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.

As part of its QIDP designation, Zerbaxa was given priority review, which provides an expedited review of the drug’s application. The QIDP designation also qualifies Zerbaxa for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.

For more information, please visit:  Zerbaxa


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