USFDA disapproves Sun Pharma unit's product in present form

NEW DELHI: Sun Pharma Advanced Research Company today said the US health regulator has disapproved its New Drug Application (NDA) for an anti-depressant product in its present form.

The US Food and Drug Administration ( USFDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300 mg tablets, Sun Pharma Advanced Research Company ( SPARC) said in a statement.

SPARC said it is in receipt of a Complete Response Letter, a communication from the USFDA that a new drug application cannot be approved in its present form.

"Based on the FDA's feedback, SPARC is evaluating the commercial viability of this product," it added.

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

Shares of SPARC rose 0.15 per cent to Rs 163.80 at the close on the BSE.