ertugliflozin and metformin hydrochloride

FDA Drug Profile — SEGLUROMET

Drug Details

Generic Name
ertugliflozin and metformin hydrochloride
Brand Names
SEGLUROMET
Application Number
NDA209806
Sponsor
MSD International GmbH (Puerto Rico Branch) LLC
NDC Codes
8
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
ERTUGLIFLOZIN PIDOLATE, METFORMIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE SEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ].