alogliptin and metformin hydrochloride

FDA Drug Profile — alogliptin and metformin hydrochloride, KAZANO

Drug Details

Generic Name
alogliptin and metformin hydrochloride
Brand Names
alogliptin and metformin hydrochloride, KAZANO
Application Number
NDA203414
Sponsor
Padagis Israel Pharmaceuticals Ltd
NDC Codes
9
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ALOGLIPTIN BENZOATE, METFORMIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. KAZANO is a combination of alogliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use KAZANO is not recommended for use in patients with type 1 diabetes mellitus.