SPARC falls after FDA response on Venlafaxine NDA

The stock has dipped 5% to Rs 155 after the USFDA said it cannot be approved NDA in its present format.

Sun Pharma Advanced Research Company (SPARC) has dipped 5.5% at Rs 155 after the US Food and Drug Administration (USFDA) said it cannot be approved new drug application (NDA) in its present format.

The company has announced receipt of a complete response letter from the USFDA on its NDA for Venlafaxine extended- release tablets, 300 mg, an anti-depressant product.

A complete response letter is a communication from the FDA to companies that an NDA cannot be approved in its present form, SPARC said in a regulatory filing.

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

The stock opened at Rs 155 and hit a low of Rs 149 on the NSE. A combined 848,971 shares have changed hands on the counter so far on the NSE and BSE.