Infectious Disease Archives - Renal and Urology News

Infectious Disease

Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies

The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.

Fetroja Approved for Complicated UTI in Patients With Limited or No Alternative Tx Options

The Food and Drug Administration (FDA) has approved Fetroja (cefiderocol; Shionogi) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. The treatment is indicated for patients aged ≥18 years with limited or no alternative…

Aztreonam + Avibactam Combo Therapy Granted QIDP, Fast Track Status for Antibiotic-Resistant Infections

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation and Fast Track designation to ATM-AVI (aztreonam and avibactam; Allergan) for the treatment of complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).  Aztreonam is a monobactam that has activity against metallo β-lactamase…

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