Zydus Cadilla gets preliminary USFDA nod for diabetes treatment

Zydus Cadila has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Tablets used for controlling blood sugar levels.

“This is a fixed dose combination of two anti-diabetic drugs indicated for Type II diabetes mellitus and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad,” the company said.

A tentative approval is issued to the applicant when the application is approvable prior to the expiration of any patents or exclusivities accorded to the reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent and exclusivity issues have expired.

Metformin works by decreasing glucose production in the liver and decreasing absorption of glucose by the intestines.

Sitagliptin regulates the levels of insulin the body produces after eating.

Metformin and sitagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.