BAXDELA is well tolerated
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
1. Data on file (included in BAXDELA New Drug Application). Melinta Therapeutics, Inc.; 2016.
aHy's law is a rule of thumb that a patient is at high risk of a fatal drug-induced liver injury if given a medication that causes hepatocellular injury with jaundice.
Melinta Therapeutics, Inc. - The Antibiotics Company
For additional information about BAXDELA, call Melinta Therapeutics at 1-844-MED-MLNT (1-844-633-6568) or contact the US Food and Drug Administration at 1-888-INFO-FDA (1-888-463-6332).