Zydus Lifesciences announced that it has now received final approval from the Food and Drug Administration (FDA) of the United States to market Empagliflozin and Metformin Hydrochloride tablets.
The Empagliflozin and Metformin Hydrochloride tablets are used with exercise, and proper diet to improve glycemic control in adults with the Type 2 diabetes mellitus. They are also used for decreasing the risk of cardiovascular death in the patients with Type 2 diabetes mellitus, and has established cardiovascular disease.
The Type 2 diabetes drug will be manufactured at the formulation facility of the group at Ahmedabad, India. According to the data, the tablets had annual sales of 281 million dollars in the United States.
Currently, the group has a total of 316 approvals, and has filed more than 420 ANDAs (Abbreviated New Drug Applications) since the commencement of the filing process in financial year 2003-2004.
The company said that it has now launched the molecule Sitagliptin in India under the brand names Siglyn and Sitaglyn to address Type 2 diabetes in India. Both brands will now add on to a comprehensive solution for the management of Type 2 diabetes by giving access to quality care to the patients at an affordable cost, and around 60 percent lesser than the originator.