Actavis' superbug antibiotic gets U.S. approval

Reuters Health Information: Actavis' superbug antibiotic gets U.S. approval

Actavis' superbug antibiotic gets U.S. approval

Last Updated: 2015-02-25

By Reuters Staff

(Reuters) - The U.S Food and Drug Administration has approved Actavis Plc's antibiotic Avycaz (ceftazidime-avibactam) to treat two infections caused by drug-resistant bacteria.

The decision comes after a panel advising the agency recommended approval of the drug in December.

The FDA approved Avycaz to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.

"The FDA is committed to making therapies available to treat patients with unmet medical need," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"It is important that the use of Avycaz be reserved to situations when there are limited or no alternative antibacterial drugs for treating a patient's infection," he said.

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