FDA has granted tentative approval for Caraco Pharmaceutical Laboratories' Abbreviated New Drug Application (ANDA) for Repaglinide Tablets USP (repaglinide), 0.5mg, 1mg and 2mg.
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(R), a registered trademark of Novo Nordisk Pharmaceuticals, Inc. Prandin(R) tablets had U.S. sales of approximately $153 million for the 12-month period ended June 30, 2007, according to IMS Data.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval. 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."
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.
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