The U.S. Food and Drug Administration approved a supplemental New Drug Application for Shionogi & Co. Ltd.’s Fetroja (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
FDA Approves Expanded Use For Merck’s Zerbaxa For Treatment Of Adults With HABP/VABP
Antibacterials, Approvals, Biopharmaceutical, Clinical Data, Drug-resistant bacteria, FDA, FDA/Regulatory, Gram-negative microorganisms, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP), Supplemental New Drug Application (sNDA)The U.S. FDA approved Merck’s supplemental New Drug Application for the use of Zerbaxa for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.