Aurobindo Pharma gets USFDA nod for Repaglinide tablets

NEW DELHI: Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market generic Repaglinide tablets that are used as an adjunct to diet in diabetic patients.

The approval is for multiple strengths of the drug in 0.5mg, 1mg and 2mg. The product is ready for launch, the company said in a statement.

The Repaglinide tablets are the generic equivalent of Novo Nordisk Prandin Tablets. These are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it added.

Quoting IMS data, the company said the market size of the product is estimated to be USD 274 million for the twelve months ending November 2013.

Aurobindo now has a total of 189 abbreviated new drug approvals from USFDA.

Shares of Aurobindo Pharma were trading at Rs 433 per scrip in the afternoon trade, down 0.74 per cent from previous close, on the BSE.