SPARC, Sun Pharma slide as USFDA rescinds approval to drug

Shares of Sun Pharma Advanced Research Company today fell by almost 3 per cent as the US health regulator has revoked its earlier approval of its new drug application for Elepsia XR, an anti-epileptic drug.
The stock declined 2.62 per cent to settle at Rs 375.80 on BSE. Intra-day, it lost 4.5 per cent to Rs 368.50.
On NSE, shares of the company fell 2.97 per cent to Rs 375.35.
Sun Pharma's scrip also lost 3.42 per cent to Rs 860.80 on BSE.
"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) had said in a statement on Friday.

The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialisation, it said.
"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 was to be manufactured at Sun Pharmaceutical Industries's Halol facility.