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FDA approves Indian Sun's generic AD drug

The US FDA has approved Indian company Sun Pharma's generic equivalent of Forest Laboratory's Alzheimer's disease treatment Namenda 

The US Food and Drug Administration (FDA) has approved Indian company Sun Pharma's Abbreviated New Drug Application (ANDA) to market a generic equivalent of Forest Laboratory's Alzheimer's disease (AD) treatment Namenda (memantine). Sun will receive 180 days of sales exclusivity on the drug which will be sold in 5mg and 10mg tablets.

The Mumbai-based company said that 5mg and 10mg strengths of memantine have combined annual sales of around $1.2bn in the US.

Memantine is the first in a novel class of Alzheimer's disease medications, which work by acting on the glutamatergic system, blocking NMDA glutamate receptors.

Memantine is also sold by Merz as Akatinol, by Lundbeck as Ebixa and Abixa and by Unipharm as Memox.

6th May 2010

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