Aurobindo Pharma receives US FDA approval for Divalproex

The Hyderabad-based Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Divalproex sodium extended-release tablets USP 250 mg and 500 mg. The company is planning to launch the product very soon.
 
Divalproex sodium extended-release tablets USP 250 mg and 500 mg is the generic equivalent of AbbVie Inc’s Depakote ER extended-release tablets, 250 mg and 500 mg respectively and indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. The product has a market size of approximately $ 690 million for the twelve months ending March 2014, according to IMS.
 
This abbreviated new drug application (ANDA) has been approved out of Unit VII (SEZ) formulation facility in Hyderabad. Aurobindo now has a total of 194 ANDA approvals (168 final approvals including 7 from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.