Lupin gets tentative approval to sell two type 2 diabetes drugs in America

Lupin Ltd on 23 July announced that it had received tentative approval from the United States Food and Drug Administration (US FDA)—the top government drug agency in the US—to sell type 2 diabetes medicines empagliflozin and linagliptin in that country.

Data show that roughly 10% of the American population lives with type 2 diabetes—a metabolic disorder in which the body is unable to properly utilize blood glucose for energy. Needless to say, lifestyle-linked diabetes is a major health concern in the US (as it is in India).

Empagliflozin and linagliptin are generic versions of Glyxambi®, developed by the German pharmaceutical company Boehringer Ingelheim Pharmaceuticals, Inc. These tablets are used jointly with diet control and exercise to improve blood sugar levels in adults with type 2 diabetes.

After receiving approval from the FDA, Lupin issued a statement saying that the company had been given experimental approval for these drugs. Under tentative approval, the FDA has allowed Lupin to sell these drugs with the strengths of 10 mg / 5 mg and 25 mg / 5 mg.

More about the drugs
What is type 2 diabetes?

More about the drugs

Empagliflozin and linagliptin are taken together. While empagliflozin helps to remove more sugar from the kidneys to prevent organ damage, nerve damage and eye problems as a result of diabetes, linagliptin induces the body make more insulin.

Insulin is a hormone that enables the passage of glucose molecules from the blood into various cells where it (the glucose) is used for energy production. In diabetics, the body is either unable to make enough insulin or it is unable to use it properly.

There are some side effects of the drugs, too. Empagliflozin may cause problems related to urination such as frequent urination or little or no urination, urethral infection, itching in the genitals, rashes, headache, diarrhoea, hypokalemia (potassium deficiency), increased cholesterol and fatigue.

The side-effects of linagliptin include runny nose, sore throat, cough, diarrhoea, vomiting, itching, loss of appetite, anxiety, depression, etc.

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What is type 2 diabetes?

It is the most common form of diabetes. Due to type 2 diabetes, the level of sugar in the blood increases to over 140mg/dL.

Though this disease is more common in the elderly, it can also develop in young people and sometimes in children.

The symptoms of this disease depend on the amount of sugar in the blood. Most patients experience excessive thirst, frequent urination, sluggishness and fatigue, sleepiness, blurred vision and increased appetite.

It is not possible to cure type 2 diabetes. It can only be controlled with certain types of treatment—healthy eating, exercise, periodic sugar testing and taking your medicine regularly are all important for the management of type 2 diabetes.