Sun Pharmaceutical Industries Ltd. has announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prandin, repaglinide tablets.
Repaglinide tablets, 1 mg and 2 mg are therapeutic equivalents of Novo Nordisk’s Prandin tablets. 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’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.