The US regulator approved the company’s abbreviated new drug applications (ANDA) for Repaglinide tablets, 1mg and 2mg, which are therapeutic equivalents of Novo Nordisk’s Prandin tablets.
Indicated as an adjunct to diet and exercise, Repaglinide tablets are developed to improve glycemic control in adults with type-2 diabetes mellitus.
Annual sales of the tablets were approximately $200m in the US, according to the company.