Bexagliflozin

FDA Drug Profile — BRENZAVVY, Bexagliflozin

Bexagliflozin is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including BRENZAVVY, Bexagliflozin. Available dosage forms: tablet, powder.

Drug Details

Generic Name
Bexagliflozin
Brand Names
BRENZAVVY, Bexagliflozin
Application Number
NDA214373
Sponsor
TheracosBio, LLC
NDC Codes
5
Dosage Forms
TABLET, POWDER
Routes
ORAL
Active Ingredients
BEXAGLIFLOZIN

Indications and Usage

1 INDICATIONS AND USAGE BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. [see Warnings and Precautions ( 5.1 )] . BRENZAVVY 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 )