SITAGLIPTIN GENERICHEALTH, SITAGLIPTIN GH, SITAGLIPTIN LAPL (Lupin Australia Pty Limited)
Product name
SITAGLIPTIN GENERICHEALTH, SITAGLIPTIN GH, SITAGLIPTIN LAPL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
170 working days (255)
Active ingredients
sitagliptin hydrochloride monohydrate
Registration type
New generic medicine
Indication
SITAGLIPTIN GENERICHEALTH, SITAGLIPTIN GH, SITAGLIPTIN LAPL (film coated tablets) are indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:
- as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.
- as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.
- as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.
- as add-on combination therapy with insulin (with or without metformin).