FORXIGA (AstraZeneca Pty Ltd)
Product name
FORXIGA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
147 (255 working days)
Active ingredients
dapagliflozin propanediol monohydrate
Registration type
EOI
Indication
Chronic kidney disease
FORXIGA (film-coated tablet) is now also indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2,3 or 4 and urine ACR≥ 30 mg/g).
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available