ZYKADIA (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
ZYKADIA
Date registered
Evaluation commenced
Decision date
Approval time
209 working days (255)
Active ingredients
ceritinib
Registration type
EOI
Indication
ZYKADIA (capsules) is now also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.