Tentative FDA clearance for generic copy of Novo Nordisk diabetes product
US drugmaker Perrigo (Nasdaq: PRGO; TASE) says it has received tentative approval from the US Food & Drug Administration for its Abbreviated New Drug Application for repaglinide tablets, the generic equivalent to Prandin tablets (repaglinide tablets).
Prandin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of around $250 million, as measured by Symphony Health Solutions, says Perrigo.
Perrigo's chairman, president and chief executive Joseph 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 health care to consumers."
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