Fetroja: how long were the pivotal tox studies?

“This finding was not associated with renal degeneration in either species, even when the animals were treated for 3 months with up to 1500 mg/kg/day in rats and 1000 mg/kg/day in monkeys.”

“This finding was not associated with renal degeneration in either species, even when the animals were treated for 3 months with up to 1500 mg/kg/day in rats and 1000 mg/kg/day in monkeys.”

“With a few notable exceptions (subcutaneous dosing of mice in a developmental toxicology study and very young rats in a juvenile toxicology study), most animal studies of cefiderocol were conducted using an intravenous route of administration.”