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Aurobindo Pharma Ltd receives USFDA approval for Repaglinide Tablets

Thursday, 23 Jan 2014 03:00am EST 

Aurobindo Pharma Ltd:Receives final approval from the US Food & Drug Administration to manufacture and market Repaglinide Tablets USP 0.5mg, 1mg and 2mg.Says product is ready for launch.Says 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 2 diabetes mellitus.Says market size of the product is estimated to be $ 274 mln for the twelve months ending Nov. 2013 according to IMS.Says it has a total of 189 ANDA approvals (164 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA. 

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