ERWINASE (PPD Australia Pty Ltd)
Product name
ERWINASE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
228 (255 working days)
Active ingredients
crisantaspase
Registration type
NCE/NBE
Indication
ERWINASE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to pegylated asparaginase obtained from E. coli.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.