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Caraco Pharmaceutical Laboratories Ltd. said it received tentative approval from the United States Food and Drug Administration for the company’s Abbreviated New Drug Application for Repaglinide Tablets USP.

The Detroit-based generic drug company said Repaglinide works by lowering the blood glucose in patients with type 2 diabetes whose hyperglycemia can’t be controlled properly by diet and exercise alone.

Caraco, whose majority owner is Sun Pharmaceutical Industries Ltd. of Mumbai, India, said doses that were approved the by FDA were 0.5 mg, 1 mg and 2 mg tablets. The tentative approval is the bioequivalent to Prandin ®, registered trademark of Novo Nordisk Pharmaceuticals Inc.

“We are extremely pleased to receive this tentative approval,” said Daniel Movens, Caraco’s Chief Executive Officer in a statement. “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.”