OCALIVA (AU Pharma Pty Ltd)
Product name
OCALIVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
154 working days (255)
Active ingredients
obeticholic acid
Registration type
NCE/NBE
Indication
OCALIVA (tablets) is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.