Lupin gets US FDA nod for generic Alzheimer’s drug

US health regulator to market its memantine hydrochloride extended-release capsules, used in treating Alzheimer’s disease. The company has received final approval for the product in strengths of 7 mg, 14 mg, 21 mg, and 28 mg from the US Food and Drug Administration (USFDA). The Mumbai-based company’s product is a generic version of Allergan’s Namenda XR capsules which

are indicated for treatment of moderate to severe dementia of the Alzheimer’s type. According to IMS MAT June 2016 sales data Namenda XR capsules had US sales of USD 1.22 billion.Alzheimer’s disease was named after Alois Alzheimer (1864-1915), a German physician who studied the cells and tissues of the central nervous system.

Alzheimer’s disease is an illness of the brain. It causes large numbers of nerve cells in the brain to die. This affects a person’s ability to remember things, think clearly, and use good judgment.

Doctors don’t know what causes the disease. They do know that most of the time it begins after age 60.

There are medicines that can treat the symptoms of Alzheimer’s disease. But, there is no cure. Most of these medicines work best for people in the early or middle stages of the disease.

Patients with Alzheimer’s disease can live as long as 20 years with the disease. The average person lives eight years after diagnosis of the condition.

Lupin gets US FDA nod for generic Alzheimer’s drug