The US Food & Drug Administration (FDA) has granted tentative approval to Perrigo Company's abbreviated new drug application (ANDA) for repaglinide tablets, the generic equivalent to Prandin tablets (repaglinide tablets).
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 its mission to provide quality, affordable healthcare to consumers."
Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API).