Lupin receives USFDA nod for generic Alzheimer treatment drug
New Delhi: Drug major Lupin Thursday said it has received approval from the 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), Lupin Ltd said in a regulatory filing.
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 $1.22 billion.
Shares of Lupin today ended at Rs 1,469.50 apiece on the BSE, down 3.10 percent from previous close.