Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
SITAGLIPTIN SUN (Sun Pharma ANZ Pty Ltd)
Product name
SITAGLIPTIN SUN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
124 (255 working days)
Active ingredients
sitagliptin fumarate
Registration type
New generic medicine
Indication
SITAGLIPTIN SUN (sitagliptin fumarate) (film-coated 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 (see 5.1 Pharmacodynamic properties, Clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine