Strong Clinical Data led to EU Approval: in late 2007, the European Medicines Agency (EMA) granted marketing authorization for Gleolan for the visualization of malignant tissue during surgery for malignant glioma (WHO grade III and IV).

Gleolan was granted approval as an orphan drug by the FDA in June 2017. NXDC anticipates the commercial launch in mid-2018. 

Gleolan FDA Approval Notice

MIDAC Meeting Minutes for Gleolan

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