Aurobindo Pharma has received US health regulator's approval to market generic version of AbbVie Inc's Depakote ER extended-release tablets, used for treating mental illness, in the American market.
The company has received final approval from US Food and Drug Administration (USFDA) to manufacture and market Divalproex Sodium Extended-release tablets in strengths of 250mg and 500mg, Aurobindo Pharma said in a statement today.
The Hyderabad-based firm said the "product is ready for launch".
Divalproex Sodium Extended-release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
As per IMS sales data, the product had a market size of around $690 million for the twelve months ended March 2014.
The company said the product has been approved out of its Unit VII (SEZ) formulation facility in Hyderabad. It now has a total of 194 abbreviated new drug application (ANDA) approvals from the USFDA.
Aurobindo shares were trading at Rs 626.95 apiece on the BSE, down 1.93 per cent from its previous close.
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