Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Divalproex Sodium Extended-release Tablets USP 250mg and 500mg. Moreover, the product is ready for launch.
Divalproex Sodium Extended-release Tablets USP 250mg and 500mg is the generic equivalent of AbbVie Inc’s Depakote ER Extended-release Tablets, 250mg and 500mg 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. The ANDAs has been approved out of Unit VII (SEZ) formulation facility in Hyderabad.
Following this, the company now has a total of 194 ANDA approvals (168 Final approvals including 7 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
