Drug maker Aurobindo Pharma on Friday said it has received the final approval from the U.S. health regulator to manufacture and market Duloxetine Hydrochloride Delayed-Release capsules, an anti-depressant drug, in the American market.
The company has received final approval from the U.S. Food & Drug Administration (USFDA) to manufacture and market 20 mg, 30 mg and 60 mg capsules of Duloxetine Hydrochloride, Aurobindo Pharma said in a statement.
It was earlier tentatively approved by USFDA. Duloxetine Hydrochloride Delayed-Release Capsules are indicated for the treatment of major depressive disorders and falls under the neurological therapeutic category.
“The market size of the product is estimated to be $5.4 billion for the twelve months ending September 2013,” said Aurobindo Pharma.
The drug maker has a total of 188 Abbreviated New Drug Application (ANDA) approvals from USFDA, of which 163 are final approvals and 25 are tentative approvals.
The shares of Aurobindo Pharma were trading at Rs. 306.70 apiece during afternoon trade at BSE, up 2.94 per cent from its last close.