Sun Pharma group stocks falter 3-4% on USFDA denial for its antiepileptic drug

Shares of listed pharma companies Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company were down around 3-4 percent in early trade Monday, after the USFDA reneged by denying approval to its new drug application for Elepsia XR, an anti antiepileptic drug. At 9.45 am, shares of Sun Pharmaceutical Industries was quoted at Rs 858, down 3.7 percent while Sun Pharma Advanced Research Company was traded at Rs 373.30, down 3.3 percent. [caption id=“attachment_2159087” align=“alignleft” width=“380”] Reuters[/caption] Fall in pharma heavyweight stock saw BSE Healthcare index drop 0.5 percent as against 0.2 percent declined in benchmark Sensex. The US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to the company’s new drug application (NDA) for Elepsia XR, Sun Pharma Advanced Research Company (SPARC) said in a statement on Saturday. The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialisation. “However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval,” it said. Elepsia XR is to be manufactured at Sun Pharmaceutical Industries’ Halol facility. The Mumbai-based drug major is working with USFDA in resolving the current good manufacturing practice (cGMP) deviations at the facility and has taken several corrective measures.