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Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Memantine Hydrochloride tablets used in the treatment of moderate to severe dementia of the Alzheimer’s type.
The product is ready for launch, the Hyderabad-based company said in a release issued here on Thursday.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product, Namenda, of Forest Laboratories Inc.
The estimated market size of the approved product was $1.23 billion in the 12 months ended August 2015, the release said.
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