SITAGLIPTIN SANDOZ (Sandoz Pty Ltd)
Product name
SITAGLIPTIN SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
139 working days (255)
Active ingredients
sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
SITAGLIPTIN SANDOZ (tablet) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to intolerance; or
- in combination with other anti-hyperglycaemic agents, including insulin
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine