The US health regulator has rejected Sun Pharma Advanced Research Company’s (SPARC) new drug application for Elepsia XR, an anti-epileptic drug.
SPARC has said in a regulatory filing that the company has received a Complete Response Letter (CRL) from the USFDA for its new drug application for Elepsia XR, Levetiracetam extended-release tablets in strengths of 1,000 mg and 1,500 mg.
It further said that “Satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XRTM can be granted.”
