FDA approves new antibiotic for UTIs

The Food and Drug Admninistration has approved a new combo antibiotic drug to be prescribed as treatment for complicated intra-abdominal infections and complicated urinary tract infections, including those involving Klebsiella pneumoniae and Escherichia coli.

The drug, to be marketed as Zerbaxa, is a combination of a cephalosporin antibacterial and a beta-lactamase inhibitor. The one-two punch enhances the drug’s potential in fighting stubborn pathogens, notes Cubist Pharmaceuticals, Lexington, Mass., the drug’s manufacturer.

The drug is the fourth new anitibotic to emerge this year from the FDA’s Generating Antibiotic Incentives Now program, designed to fast-track the approval process for drugs that combat serious or resistant infectious diseases.

“We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in an FDA statement. “We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility.”


Topics: Clinical