Sun Pharmaceutical Industries’ subsidiary has been granted a final approval from USFDA for its Abbreviated New Drug Applications (ANDA) for generic version of Prandin, Repaglinide tablets. Sun Pharma’s subsidiary, being the first-to-file an ANDA for generic Prandin with a Para IV certification, is eligible for a 180-day marketing exclusivity in the US.
Repaglinide tablets, 1 mg and 2 mg are therapeutic equivalents 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 type-2 diabetes mellitus.
Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.
