Bexagliflozin

FDA Drug Profile — Bexagliflozin, BRENZAVVY

Drug Details

Generic Name
Bexagliflozin
Brand Names
Bexagliflozin, BRENZAVVY
Application Number
NDA214373
Sponsor
TheracosBio, LLC
NDC Codes
4
Dosage Forms
TABLET, POWDER
Routes
ORAL
Active Ingredients
BEXAGLIFLOZIN

Indications and Usage

1 INDICATIONS AND USAGE Bexagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Bexagliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . Bexagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitation of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )