Sitagliptin Hydrochloride Oral
Drug Details
- Generic Name
- Sitagliptin Hydrochloride Oral
- Brand Names
- BRYNOVIN
- Application Number
- NDA219122
- Sponsor
- Azurity Pharmaceuticals, Inc.
- NDC Codes
- 1
- Dosage Forms
- SOLUTION
- Routes
- ORAL
- Active Ingredients
- SITAGLIPTIN
Indications and Usage
1 INDICATIONS & USAGE BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using BRYNOVIN. [see Warnings and Precautions ( 5.1 )] . BRYNOVIN is 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 ) Limitations of Use: • BRYNOVIN is not recommended in patients with type 1 diabetes. ( 1 ) • BRYNOVIN has not been studied in patients with a history of pancreatitis. ( 1 )