Aurobindo Pharma today said it has received tentative approval from the US health regulator to market its generic Venlafaxine capsules used for treating major depressive disorder (MDD)
In a filing to the Bombay Stock Exchange (BSE), the company said the tentative approval from the United States Food and Drug Administration (USFDA) is for multiple strengths of 37.5 mg, 75 mg and 150 mg of Venlafaxine Extended Release Capsules.
These capsules are generic equivalent of Wyeth Pharmaceuticals's Effexor XR capsules in the strengths of 37.5 mg, 75 mg and 150 mg, it added.
The company claimed that it had filed for the approval under Paragraph IV certification, which would have given it 180 days of marketing exclusivity but it is currently under litigation in the US District Court of New Jersey.
It further added that the product will be launched after the litigation settlement.
"According to IMS, the product has a market size of approximately $2.4 billion for the twelve months ending September 2010," Aurobindo Pharma said.
Shares of Aurobindo Pharma were today trading at Rs 166.70 in the afternoon trade on BSE, down 18.66% from its previous close.
Yesterday, the company had said the USFDA has issued an import alert on products from its Hyderabad-based cephalosporin
Facility, as a result of which its exports to the US market would be affected.