SPARC spikes 7% on USFDA's complete response letter for Xelpros

Moneycontrol Bureau

Shares of Sun Pharma Advanced Research Company (SPARC), the subsidiary of healthcare major Sun Pharmaceutical, surged nearly 7 percent intraday Thursday after receiving complete response letter from the US health regulator for preservative-free eye drop.

"...has received a complete reponse letter from the US Food and Drug Administration for the new drug application for Xelpros, Latanoprost BAK-free eyedrops," the research company said in its filing.

It further said the complete response letter was related to the recent inspection of the Sun Pharma's Halol manufacturing facility (in Gujarat) by the USFDA and indicated that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros.

In the complete response letter, the US FDA has not asked for any additional data.

SPARC had out-licensed Xelpros to a subsidiary of Sun Pharma in June 2015.

Initially in December, the USFDA issued form-483, citing nine observations after inspecting the Halol facility during November 17-December 1. None of those observations were characterised by the USFDA as repeat observations, the company had said in its filing on December 8.

At 12:31 hours IST, the stock was quoting at Rs 317.60, up Rs 10.20, or 3.32 percent amid high volumes on the BSE.Posted by Sunil Shankar Matkar