Sun Pharma gate US FDA rod for Exelon

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New Delhi, Oct 23 (UNI) Pharma firm Sun Pharmaceutical Industries Ltd today said it has received US FDA approval to market generic version of Novartis Exelon.

The generic rivastigmine capsules are AB-rated available in four strengths of 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 disease.

Exelon have annual sales of about 200 million dollars in the US, a statement said.

Sun Pharma, being one of the first-to-file an ANDA for generic Exelon with a para IV certification, shares a 180-day marketing exclusivity, in view of the ongoing litigation with Novartis on this product.


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