Sun Pharma gets USFDA nod for generic diabetes tablets
New Delhi: Drug firm Sun Pharmaceutical Industries today said it has received final approval from the US health regulator for its generic Repaglinide tablets used for treatment of diabetes.
The company is eligible for a 180-day marketing exclusivity in the US as its subsidiary is the first-to-file an abbreviated new drug applications (ANDA) for the product with a para IV certification, it added.
United States Food and Drug Administration (USFDA) has granted final approval to company`s subsidiary for its ANDA for generic version of Repaglinide tablets in the strengths of 1 mg and 2 mg, Sun Pharma said in a statement.
The company`s tablets in both the strengths are generic versions of Novo Nordisk`s Prandin tablets, it added.
"These tablets have annual sales of approximately USD 200 million in the US. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus," Sun Pharma said.
Shares of Sun Pharmaceutical Industries were today trading at Rs 1,091.85 per scrip in the morning trade on BSE, down 0.30 per cent from its previous close.