Zydus Lifesciences Arm receives USFDA Tentative Approval For Canagliflozin, Metformin Hydrochloride Tablets

Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”), has received tentative approval from the United States Food and Drug Administration (USFDA) for Canagliflozin and Metformin Hydrochloride Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg (USRLD: Invokamet Tablets). Canagliflozin and metformin combination product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a metformin or canagliflozin-containing regimen or in patients already receiving both canagliflozin and metformin.

The drug will be produced at the group’s Moraiya formulation manufacturing facility. In the United States, Canagliflozin and Metformin Hydrochloride Tablets had annual sales of USD 49.4 million (IQVIA MAT Dec. 2022). The group now has 344 approvals and has filed over 440* ANDAs since the filing process began in FY 2003-04, according to the company. Zydus Lifesciences Limited had previously received tentative approval from the United States Food and Drug Administration (USFDA) to market Canagliflozin Tablets, 100 mg and 300 mg, according to the Medical Dialogues team (USRLD: Invokana Tablets).

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