Tuesday, October 23, 2007

FDA Approves Generic Alzheimer's and Parkinson's desease Drug

BANGALORE (Thomson Financial) - Sun Pharmaceutical Ltd said the US Food and Drug Administration has approved its application to market its generic version of Novartis' Exelon capsules.

It is primarily used for treating Alzheimer's and Parkinson's diseases. In a filing to the Bombay Stock Exchange, the firm informed that the USFDA had granted the final approval for its Abbreviated New Drug Application (ANDA) to market the generic version of Novartis Exelon capsules.

The generic version of rivastgmine tartrate capsules (Exelon) comes in four strengths, 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). Rivastgmine tartrate is indicated for the treatment of mild to moderate dementia of the Alzheimer's type and for the treatment of mild to moderate dementia associated with Parkinson's diseas

The Mumbai-based company said in view of the ongoing litigation with Novartis on this product, it is evaluating all its launch options. Sun Pharma said it shares a 180-day marketing exclusivity.

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