Aurobindo gets USFDA nod to market mental illness drug

Aurobindo Pharma has received US health regulator's approval to market generic version of AbbVie

RELATED ARTICLES

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.

Post new comment

E-mail ID will not be published
CAPTCHA
This question is for testing whether you are a human visitor and to prevent automated spam submissions.

EDITORIAL OF THE DAY

  • Tax collections are a more reliable indicator of economic growth

    Direct taxes collection figures are supposed to reflect the health of corporate bottomlines as well as the state of the overall economy.

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

Learning the art of learning styles

Recently, I met a group of new teachers from different ...

Rajgopal Nidamboor

The essence of creative energy

Creativity or originality isn’t the privilege of working minds, even ...

Gautam Gupta

Indian designers can learn a lot from Benetton

I was reading an article in the magazine about Benetton ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture