FDA gives final approval to Perrigo's ANDA for repaglinide tablets 1 mg and 2 mg

Perrigo Company plc (NYSE: PRGO; TASE) today announced that it has received final approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for repaglinide tablets 1 mg and 2 mg, the generic equivalent to Prandin® Tablets (repaglinide tablets) and has commenced shipment of product. Perrigo previously launched the 0.5 mg strength in 2013.

Prandin® tablets (repaglinide tablets), are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of approximately $250 million, as measured by Symphony Health Solutions.

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "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 healthcare to consumers."