Pharmaceutical Business review

Bayer HealthCare Gadavist injection gets FDA approval

According to Bayer HealthCare, Gadavist demonstrated improvement of visualization endpoints in paired Gadavist images compared to pre-contrast images resulted in improved assessment of normal and abnormal CNS anatomy in two Phase III trials.

Bayer HealthCare Commercial Operations John Rotondo said the approval of Gadavist enriches their portfolio of MRI contrast media and provides a new option for US healthcare providers in contrast-enhanced imaging of the CNS.