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E-mail ID will not be published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.
Image CAPTCHA
Copy the characters (respecting upper/lower case) from the image.

EDITORIAL OF THE DAY

  • India would have done well not to supress the 'Bofors interview'

    Bofors is one case that refuses to go away two-and-half decades after it grabbed public attention and became a byword for political corruption, claimi

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

Varun Dutt

THE BLAME GAME

In decision-making, the fundamental attribution error (FAE), also known as ...

Zehra Naqvi

Dignity of labour is dignity of life

M Rafi Khan, a retired police IG, used to ...

Gautam Gupta

Retailers have it tough, thanks to e-commerce

For the past few months our focus has been on ...

INTERVIEWS

William D. Green

Chairman & CEO, Accenture