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DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.
"This approval shows the talent and expertise of our R&D and regulatory affairs departments. This is another example of Perrigo's commitment to bring new products to market and deliver on our mission to provide quality, affordable health care to consumers," said Joseph C. Papa, Perrigo's Chairman, president and CEO.
Prandin is used to improve glycemic control in adults with Type 2 diabetes. Annuals sales of Prandin tablets are approximately $250 million, according to Symphony Health Solutions.