Zydus Lifesciences gets FDA tentative approval for Invokamet generic

Zydus Lifesciences said that its subsidiary Zydus Pharmaceuticals (USA) has been granted tentative approval for Canagliflozin and Metformin Hydrochloride Tablets, 50mg/500mg, 50mg/1,000mg, 150mg/500mg, and 150mg/1,000mg from the US States Food and Drug Administration (FDA).

The Canagliflozin and Metformin Hydrochloride regimen is a generic version of Invokamet Tablets. It is intended to be used as an adjunct to diet and exercise for enhancing glycemic control in type 2 diabetes mellitus adults who are not controlled adequately on a regimen containing metformin or canagliflozin or in patients already under treatment with both canagliflozin and metformin.

Zydus Lifesciences will manufacture Canagliflozin and Metformin Hydrochloride Tablets at its Moraiya formulation manufacturing facility in Gujarat.

Zydus Lifesciences gets FDA tentative approval for Invokamet generic. Photo courtesy of Zydus Cadila.

As per IQVIA MAT December 2022, the annual sales of Canagliflozin and Metformin Hydrochloride Tablets in the US is estimated at $49.4m.

Zydus Lifesciences has 344 approvals now and has so far submitted more than 440 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.