NEW DELHI, Oct 15: Drug major Aurobindo Pharma today said it has received final approval from the US FDA to manufacture and market Memantine Hydrochloride tablets used in treatment of Alzheimer’s.
“The company has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market Memantine Hydrochloride Tablets, 5mg and 10mg (ANDA 203175),” Aurobindo Pharma said in a BSE filing.
It further said: “This approval is an extension of tentative approval received on March 24, 2014. The product is ready for launch.”
Aurobindo Pharma said the approved ANDA (Abbreviated New Drug Application) is bioequivalent and therapeutically equivalent to the reference listed drug product Forest Laboratories Inc’s Namenda.
Memantine Hydrochloride Tablets are used for the treatment of moderate to severe dementia of the Alzheimer’s type.
Quoting IMS data, the company said, the approved product has an estimated market size of USD 1.23 billion for 12 months ending August 2015.
Aurobindo Pharma now has a total of 215 ANDA approvals (188 final approvals including 10 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.
Shares of Aurobindo Pharma were trading at Rs 813 apiece, up 0.90 per cent, from their previous close on the BSE. (PTI)
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