Lupin gets USFDA approval for generic Alzheimer treatment capsule
Pharma major Lupin on Thursday said it has received final approval from the US health regulator to market its memantine hydrochloride extended-release capsules, which are used in the treatment of the Alzheimer's disease.
"....the company has received final approval for its Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, and 28 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Allergan’s Namenda XR Capsules, 7 mg, 14 mg, and 28 mg," Lupin said in a filing to the BSE.
The company's product are the AB rated generic equivalent of Allergan’s Namenda Capsules, which are indicated for the treatment of moderate to severe dementia of the Alzheimer's type, it said.
According to IMS MAT June 2016 data, the Nameda XR Capsules had US sales of $1.22 billion (nearly Rs 8,116.4 crore).
The stock of Lupin has closed down 3.10% or Rs 47.05 at Rs 1,469.50 on the BSE on Thursday.