Aurobindo Pharma Ld has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Repaglinide tablets. The product is ready for launch.
The tablets are the generic equivalent of Novo Nordisk Inc’s Prandin tablets and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The market size of the product is estimated to be $274 million for the 12 months ended November 30, 2013, according to IMS.
The Hyderabad-based company now has a total of 189 Abbreviated New Drug Approvals (ANDA) approvals (164 final approvals, including seven from Aurolife Pharma LLC and 25 tentative approvals) from the US regulator, according to a release.