Potential Tx for CRE Infections Fast Tracked by the FDA
The Medicines Company announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI).
Carbavance is currently being investigated in 2 ongoing TANGO (Targeting Antibiotic Non-
The FDA previously granted Carbavance Qualified Infectious Disease Product (QIDP) designation for cUTIs, intra-abdominal infections, HABP/VABP, and febrile neutropenia in 2014.
Carbavance, the combination of meropenem (carbapenem antibiotic) and vaborbactam (novel beta-lactamase inhibitor), is an investigational agent being developed for the treatment of gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).
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