alogliptin and pioglitazone

FDA Drug Profile — OSENI

Drug Details

Generic Name
alogliptin and pioglitazone
Brand Names
OSENI
Application Number
NDA022426
Sponsor
Takeda Pharmaceuticals America, Inc.
NDC Codes
4
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ALOGLIPTIN BENZOATE, PIOGLITAZONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. OSENI is a combination of alogliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: OSENI is not recommended for use in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use OSENI is not recommended for use in patients with type 1 diabetes mellitus.