aThe data are not an adequate basis for comparison of rates between the study drug and the active control.
bPooled reports include hypertransaminasaemia, increased transaminases, and increased ALT and AST.
Difference in discontinuation rate is not statistically significant.
QT prolongation was not observed in patients taking BAXDELA in a QT study
Photosensitivity was not observed in patients taking BAXDELA in a photosafety study
No cases of Hy’s lawa were reported in the BAXDELA clinical trials1
The incidence of dysglycemia in the BAXDELA arm was similar to the incidence observed with vancomycin plus aztreonam in Phase 3 ABSSSI trials1
Minimal potential for drug interactions demonstrated during development
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Please refer to Important Safety Information.
1. Data on file. Melinta Therapeutics, LLC.
aHy's law is an indicator of a drug's potential to cause serious liver injury.
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