Sun Pharma Advanced Research Company (SPARC) on Friday announced that the U.S. Food and Drug Administration (USFDA) has revoked its 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. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.

Shares of the company declined Rs 9.5, or 2.46%, to trade at Rs 376.40. The total volume of shares traded was 89,378 at the BSE (10.58 a.m., Monday).