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Sun Pharma gets tentative FDA nod

By PTI Apr 10 2010 , New Delhi

Tags: Drug, Sun Pharmaceutical, USFDA, Companies

Sun Pharmaceutical Industries today announced that its US-based subsidiary has got tentative approval from

the Food and Drug Administration to market a generic drug for the treatment of Alzheimer's disease.

Sun Pharma has submitted an Abbreviated New Drug Application to the FDA seeking approval to market its generic Memantine tablets in 5 and 10 mg strengths in the US.

The Memantine tablets are therapeutically equivalent to Forest Laboratories' Namenda tablets. Namenda is a patented drug from Forest Laboratories' portfolio for the treatment of moderate to severe Alzheimer’s disease.

Namenda sales have exceeded USD 1.2 billion in the US.

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