Sun Wins FDA Approval For Rivastigmine Tartrate
Mumbai: Sun Pharmaceutical Industries has got nod from USFDA to promote the generic version of Novartis’s Exelon capsules ‘Rivastigmine Tartrate.’
Rivastigmine Tartrate is used for the treatment of Alzheimer’s and Parkinson’s disease.
Sun gets FDA authorization for 1.5mg, 3mg, 4.5mg and 6mg drug potencies.
The yearly sales of Exelon capsules in the US market would be around $200 million in these strengths.
The India’s largest drug manufacturer by market value told that it would share 6-months (180-days) marketing exclusivity in the US for the drug.
It is the first to register the abbreviated new drug application (ANDA) for the generic drug.
Sun said, “In view of the ongoing litigation with Novartis on this product, the company is evaluating all launch options.”
Sun Pharma’s shares ended 2.8 percent up at Rs 1,007.50 on yesterday, whereas the BSE Sensex gained 5 percent.