Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company (SPARC) witnessed a fall in share price on Monday after the U.S. Food and Drug Administration (USFDA) has revoked SPARC's new drug application (NDA) for Elepsia XRTM (Levetiracetam extended-release tablets 1000 mg and 1500 mg).
SPARC has received a complete response letter from the USFDA rescinding approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.
Earlier, the company had received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization.
Elepsia XR TM is to be manufactured at Sun Pharmaceutical Industries (SPIL)'s Halol facility.
Shares of Sun Pharmaceutical Industries are trading at Rs 864.45, down Rs 26.85, or 3.01% at the Bombay Stock Exchange (BSE) on Monday at 11:11 a.m.
Shares of SPARC are trading at Rs 376.20, down Rs 9.7, or 2.51% at the Bombay Stock Exchange (BSE) on Monday at 11:11 a.m.