Regulatory & Safety

FDA says ‘threat of AMR’ behind Merck antibiotic label expansion

Zerbaxa (ceftolozane and tazobactam) was previously approved by the US Food and Drug Administration (FDA) for the treatment of complicated intra-abdominal infections and for complicated urinary tract infections. Yesterday, the FDA added hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) to the antibiotic’s label. “A key global challenge we face Czytaj więcej…