New drug combo wins FDA approval to treat UTIs, intra-abdominal infections
New antibiotic drug combo wins FDA approval
HealthDay News -- Combination antibiotic ceftolozane/tazobactam (Zerbaxa) has been approved by the United States Food and Drug Administration (FDA) to treat adult patients with complicated intra-abdominal infections and complicated urinary tract infections.
The approval for intra-abdominal infections is for use of ceftolozane/tazobactam in combination with another drug, metronidazole, the agency said in a news release. The approval for urinary tract infection includes pyelonephritis.
Ceftolozane/tazobactam is the fourth antibiotic to be FDA approved in 2014, following approval of dalbavancin (Dalvance), tedizolid (Sivextro ), and oritavancin (Orbactiv).
The drug's label includes a warning about decreased effectiveness among people with renal impairment, noted the agency. The most common side effects reported during clinical testing included nausea, diarrhea, headache, and pyrexia.
Zerbaxa is marketed by Cubist Pharmaceuticals, based in Lexington, Mass.