Sun Pharma gets USFDA approval

Sun Pharmaceutical Industries Ltd has announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Exelon®, rivastigmine tartrate capsules.

These generic rivastigmine capsules are AB-rated equivalent of Novartis Exelon® Capsules and include four strengths: 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base). These strengths of Exelon® have annual sales of approximately USD 200 million in the US.

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, the Company is evaluating all its launch options.

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.