This Article is From Sep 12, 2012

Aurobindo Pharma gets US drug regulator's approval for anti-depressant

Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture and market generic version of anti-depressant Lexapro in the American market.

The approval by the US Food & Drug Administration (USFDA) is for multiple strengths of escitalopram oxalate tablets in 5mg, 10mg and 20mg, the company said in a statement.

The escitalopram oxalate tablets are generic equivalent of Forest Laboratories Inc's patented Lexapro, it said, adding "the product is ready for launch".

The drug is indicated for treatment of depression associated with mood disorders.

Citing IMS data, the company said Lexapro had a market size of approximately USD 2.8 Billion for the twelve months ended March 2012.

"The product has been approved out of Unit III formulations facility in Hyderabad," the company said.

Aurobindo now has a total of 158 abbreviated new drug applications (ANDA) approvals from the USFDA. It includes 133 final approvals, including one from Aurolife Pharma LLC and 25 tentative approvals.

Aurobindo Pharma scrip was trading at Rs 130.05 in the afternoon trade on BSE, down 0.80 per cent from the previous close.