Sun Pharmaceutical Industries 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 $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.
EP News Bureau – Mumbai