Aurobindo gets USFDA nod to market mental illness drug

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 USD 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.

EDITORIAL OF THE DAY

  • Government must wake up to the woes of electricity generators

    India is not staring at a power crisis yet, but an estimated 46,000 mw of power capacities are at risk today.

FC NEWSLETTER

Stay informed on our latest news!

INTERVIEWS

Sarthak Raychaudhuri

vice-president, HR, Asia South Whirlpool of India

GV Nageswara Rao

MD & CEO, IDBI Federal Life

Timothy Moe

Goldman Sachs

TODAY'S COLUMNS

Arun Nigavekar

Moocs will not replace traditional education

I am revisiting the topic of massive open online course ...

Zehra Naqvi

Minimalism: declutter your life

When you imagine an ideal place to live, you think ...

Gautam Gupta

Our fashion schools need to notch it up

“Creativity is the key to success and primary education is ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture