Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Divalproex Sodium Extended-release tablets. The product is ready for launch.
The drug is the generic equivalent of AbbVie Inc’s Depakote ER Extended-release tablets 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 12 months ended March 31, 2014, according to IMS.
According to a release, this 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 USFDA.