saxagliptin
Drug Details
- Generic Name
- saxagliptin
- Brand Names
- Saxagliptin
- Application Number
- ANDA205980
- Sponsor
- Mylan Pharmaceuticals Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE, SAXAGLIPTIN MONOHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Saxagliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1.1 ) Limitations of use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies ( 14 ) ]. 1.2 Limitation of Use Saxagliptin tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
1.1 Monotherapy and Combination Therapy Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies ( 14 ) ].