FDA approves new indication for MSD’s Zerbaxa
pharmafile | June 5, 2019 | News story | Research and Development | Merck, Zerbaxa, bacterial infection, pharma
The FDA has approved US firm Merck’s Zerbaxa (ceftolozane and tazobactam) for adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The new indication comes after MSD’s drug was first approved for treating complicated intra-abdominal infections and urinary tract infections by the FDA in 2014.
The drug showed similar efficacy to another antibacterial drug in a clinical trial of 726 patients who had been hospitalised with HABP/VABP.
Elevated liver enzyme levels, renal impairment or failure, and diarrhea were amongst the most commonly reported adverse reactions.
Louis Goss
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