TRADEMARK (Tradename to be provided once available) Merck Sharp & Dohme (Australia) Pty Ltd
Product name
TRADEMARK (Tradename to be provided once available)
Accepted date
Mar-2024
Active ingredients
sotatercept
Proposed indication
Indicated for the treatment of pulmonary arterial hypertension
Application type
A (new medicine)
Publication date
Mar-2024
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.