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news.Caraco Pharmaceutical Laboratories has reported that the FDA has granted tentative approval for its abbreviated new drug application for repaglinide tablets in 0.5mg, 1mg and 2mg doses, for the treatment of type II diabetes mellitus.
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Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.
This tentative approval is the bioequivalent to Prandin, a registered trademark of Novo Nordisk Pharmaceuticals. Prandin tablets had US sales of approximately $153 million for the 12-month period ended June 30, 2007, according to IMS Data.
Daniel Movens, Caraco’s CEO, said: “We believe we have a first to file position on Repaglinide, which could result in 180-day marketing exclusivity. The product was filed with a paragraph IV certification that we do not infringe and or that the Novo Nordisk patent is invalid. We are under current litigation with Novo Nordisk and expect a favorable conclusion.”