FORTIC (Accord Healthcare Pty Ltd)
Product name
FORTIC
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
140 (255 working days)
Active ingredients
Mycophenolate sodium
Registration type
New generic medicine
Indication
Mycophenolic acid Intas tablets are indicated for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.
Mycophenolic acid Intas tablets are indicated for induction and maintenance treatment of adult patients with WHO Class III, IV or V lupus nephritis.
This indication is based on the evidence in literature reports of studies of treatment in patients with lupus nephritis, the majority of whom were ISN/RPS (2003) Class IV. The evidence for efficacy was based on surrogate endpoints.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine