Pharma major Lupin Limited (Lupin) said it has received tentative approval from US FDA for Empagliflozin and Linagliptin tablets used to control blood sugar levels.
The approval is for selling combinations of 10 mg+5 mg and 25 mg+5 mg of the drugs.
In these dosages, the tablets have annual sales of around 242 million in the US, the company said.
The innovator version of the tablet is called Glyxambi from Boehringer Ingelheim Pharmaceuticals, Inc.
The combination drug is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Type 2 diabetes is much more common than type 1 diabetes and is related to insulin resistance.
It happens when the cells in the body refuse to pay heed to the presence of insulin, which should ordinarily drive glucose inside the cells from the blood.
Because of this condition, known as insulin resistance, the patient’s blood sugar levels rise abnormally.
Lupin is one of India’s top makers of generic drugs, and is especially strong in areas such as cardiovascular, anti-diabetic, and respiratory diseases.
It also makes drugs in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas.
It sells branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and the Asia Pacific (APAC), Latin America (LATAM), Europe and the Middle-East.
It is the third largest pharmaceutical company in the U.S. by prescriptions and in India by global revenues and claims to spend almost 10% of its revenue on research and development.
The company has fifteen manufacturing sites and seven research centers, and more than 20,000 employees.
