Sun Pharma to sell Repaglinide diabetes drug in the US

Sun Pharmaceutical Industries has been given the green light to launch the generic version of Novo Nordisk’s Prandin diabetes drug in the United States.
The Mumbai-based drugmaker announced today that the U.S. Food and Drug Administration (FDA) has granted its subsidiary final approval for the release of repaglinide tablets in the strengths of 1 mg and 2 mg.
Repaglinide is indicated to improve blood sugar control in adults with type 2 diabetes alongside a healthy diet and regular exercise.
The drug, which belongs to a group of diabetes medications known as prandial glucose regulators (or meglitinides), works by stimulating the release of insulin by the pancreas to prevent blood sugar levels from rising toot high after meals.
The company said it would be eligible for a 180-day marketing exclusivity in the US for repaglinide as its subsidiary is the first-to-file an abbreviated new drug applications (ANDA) for the product with a para IV certification.