Aurobindo Pharma Ltd, a Hyderabad-based drugmaker, has received approval from US Food and Drug Administration (USFDA) to market the generic version of AbbVie Inc’s Depakote ER extended-release tablets, used for treating mental illness, in the American market.
Divalproex Sodium Extended-release tablets are used for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
Aurobindo received the final approval from USFDA to manufacture and market Divalproex Sodium Extended-release tablets in strengths of 250mg and 500mg, the firm said in a statement on Tuesday.
As per IMS sales data, the product had a market size of around $690 million for the 12 months ended March 31, 2014.
As per Aurobindo, the product has been approved out of its Unit VII (SEZ) formulation facility in Hyderabad. The firm now has 194 abbreviated new drug application (ANDA) approvals from USFDA.
Earlier this year, Aurobindo signed a binding offer to acquire loss-making commercial operations of Dublin-headquartered Actavis Plc in seven European countries for €30 million ($40.6 million or Rs 221 crore). Aurobindo was advised by Jefferies International Ltd and Herbert Smith Freehills LLP while Actavis was advised by Rothschild and Latham & Watkins for the deal.
Aurobindo has been increasing its API portfolio and active in acquiring firms in India. Recently it acquired Hyacinths Pharma, an Andhra Pradesh-based manufacturer of APIs, for an undisclosed amount. In another transaction, it had acquired the remaining 25 per cent stake in Silicon Life Sciences Pvt Ltd. It also struck a deal to acquire majority stake in an upcoming manufacturing unit of Celon Labs.
In the past it has also snapped firms like Hyderabad-based contract research firm Trident Life Sciences Ltd.
(Edited by Joby Puthuparampil Johnson)