3-Jun-2014 Swati Rathor HYDERABAD: City-based pharma player Aurobindo Pharma Limited on Tuesday announced that the company had received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Divalproex Sodium Extended-release tablets (USP 250mg and 500mg) in the US market. The company also stated that the product was ready for launch. Divalproex Sodium Extended-release tablets, which is the generic equivalent of AbbVie Inc's Depakote ER Extended-release tablets, is a psychiatric drug and is used in the treatment of acute manic or mixed episodes associated with bipolar disorder. According to industry estimates, the product clocked sales of approximately $690 million for the twelve months ending March 2014. The Hyderabad-based company stated that the Abbreviated New Drug Application (ANDA) of the drug has been approved out of Unit VII (SEZ) formulation facility in Hyderabad. The company now had a total of 194 ANDA approvals from the USFDA, it said. Meanwhile,during the last week the company had also reported a nearly threefold rise in the profit at Rs 1,173 crore in FY14 as compared to Rs 294 crore in FY13 on the back of higher revenues from the formulations business. This was on an income of Rs 8,099.79 crore during the financial year as against Rs 5,855.31 crore in the year ago period. Segment wise the formulations contributed revenues of Rs 5,378.5 crore in FY14 as compared to Rs 3,387 crore in FY13, while the active ingredients segment contributed revenues of Rs 2,864 crore during the fiscal as compared to Rs 2,566 crore in the previous fiscal. http://timesofindia.indiatimes.com/business/india-business/aurobindo-gets-usfda-nod-to-market-psychiatric-drug/articleshow/36010495.cms
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