US FDA disapproves Sun Pharma arm's anti-depressant

SPARC was demerged from Sun Pharmaceutical Industries Ltd as a research and drug discovery company in 2007

Sun Pharma Advanced Research Company on Tuesday said the US drug regulator had disapproved its new drug application for an anti-depressant in its present form. The US Food and Drug Administration (FDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300mg tablets, it said.

It said it was in receipt of a complete response letter, a communication from FDA that a new drug application cannot be approved in its present form. “Based on FDA’s feedback, the company is evaluating the commercial viability of this product,” it added.

The company was hived off from Sun Pharmaceutical Industries as a research and drug discovery company in 2007. Shares of the company rose 0.15 per cent to Rs 163.80 at the close on the BSE exchange.