MUMBAI, India — The Food and Drug Administration has approved a generic diabetes drug made by Sun Pharmaceutical Industries, Sun said Friday.
The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.
The drug is a generic version of Novo Nordisk's Prandin, which has annual sales of about $200 million, according to Sun. Sun filed for approval with a Paragraph IV certification, a legal assertion that Prandin's patent protection is invalid, unenforceable or not in danger of infringement. As the first company to successfully file for approval, Sun is eligible for 180 days of market exclusivity in which to compete directly with Novo Nordisk's version.
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