Zevtera: genotox, carcinogenicity and repro: done or skipped?

“However, in vivo ceftobiprole medocaril sodium was negative in both the micronucleus assay and rat liver unscheduled DNA synthesis reducing concern for potential clastogenic activity.”

“No studies were available and none are warranted for this relatively short treatment duration.”

“Intravenous administration of ceftobiprole medocaril sodium to pregnant rats and monkeys during organogenesis showed no evidence of adverse fetal developmental outcomes at doses approximately 1.4 times and 0.9 times the MRHD, respectively, based on BSA comparison.”

“Ro 63-9141-induced convulsion appears to be a primary effect and not secondary to kidney damage as convulsions were seen with direct injection into the brain.”

“Ceftobiprole medocaril was negative in a standard bacterial reverse mutation test, however, the test was limited by bactericidal activity.”

“The genotoxicity profile of ceftobiprole medocaril sodium was mixed including a negative Ames assay, a positive mouse lymphoma assay, a negative forward mutation assay, and positive chromosomal assays for both the pro-drug and active metabolite suggesting clastogenic potential.”

“However, in vivo ceftobiprole medocaril sodium was negative in both the micronucleus assay and rat liver unscheduled DNA synthesis reducing concern for potential clastogenic activity.”

“No studies were available and none are warranted for this relatively short treatment duration.”

“No studies were available and none are warranted for this relatively short treatment duration.”

“There were no differences in HERG tail current between the BAL9141 and control vehicle.”