Aurobindo Pharma has received the final approval from the US Food and Drug Administration to manufacture and market repaglinide tablets USP 0.5mg, 1mg and 2mg. The product is ready for launch.
Repaglinide tablets USP 0.5mg, 1mg and 2mg are the generic equivalent of Novo Nordisk Inc’s Prandin tablets USP 0.5mg, 1mg and 2mg and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. The market size of the product is estimated to be $ 274 million for the 12 months ending November 2013 according to IMS.
Aurobindo now has a total of 189 ANDA approvals (164 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from US FDA.
EP News Bureau- Mumbai
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