Sun Pharmaceutical Industries has received final approval from the US health regulator for its generic Repaglinide tablets used for the 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 application (ANDA) for the product with a para IV certification.
The United States Food and Drug Administration (USFDA) has granted final approval to the 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 today.
The company’s tablets in both the strengths are generic versions of Novo Nordisk’s Prandin tablets.
“These tablets have annual sales of approximately $200 million in the US. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type02 diabetes mellitus,” Sun Pharma said.
Shares of Sun Pharmaceutical Industries were trading at Rs 1,091.85 per scrip in the morning trade on BSE, down 0.30 per cent from its previous close.