ZIRDAWNY (Otsuka Australia Pharmaceutical Pty Ltd)
Product name
ZIRDAWNY
Date registered
Evaluation commenced
Decision date
Approval time
167 (255 working days)
Active ingredients
donidalorsen sodium
Registration type
NCE/NBE
Indication
ZIRDAWNY is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.