Lupin receives FDA approval for generic Namenda XR dementia capsules

Pharma Major Lupin Ltd said it received final approval from United States Food and Drug Administration for selling Memantine Hydrochloride extended-release capsules, a generic version of Allergan’s Namenda XR capsules.

Namenda XR extended-release capsules are approved by the USFDA for the treatment of moderate to severe dementia of the Alzheimer’s disease.

It does not cure Alzheimer’s disease, but it may improve memory, awareness, and the ability to perform daily functions.

Lupin’s Memantine Hydrochloride extended-release capsules are the AB rated generic equivalent of Allergan’s Namenda XR Capsules. Non-AB rate equivalents may not be substituted by the pharmacist without the permission from the doctor as they are considered therapeutic alternatives and not generic substitutes.

Namenda XR capsules had US sales of $ 1.22 Billion (IMS MAT June 2016).

Lupin manufactures a wide range of branded & generic formulations, biotechnology products and APIs globally.

For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 million ($ 2.09 billion) and Rs 22,607 million ($ 345 million) respectively.