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The US health regulator has denied approval to Sun Pharma Advanced Research Company's (SPARC) new drug application for Elepsia XR, an anti-epileptic drug.
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, SPARC said in a regulatory filing.
The USFDA has denied approval for the drug after inspecting Sun Pharma's Halol manufacturing site.
"Satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XRTM can be granted," SPARC said.
SPARC had out-licensed Elepsia XR to a subsidiary of Sun Pharma last year. Elepsia XR is to be manufactured at Sun Pharma's Halol facility.
SPARC was demerged from Sun Pharma as a pharma research and drug discovery company in 2007.
Sun Pharma is currently working with USFDA for resolving the cGMP issues at the Halol facility.
USFDA Center for Drug Evaluation and Research (CDER) no longer issues "approvable" or "not approvable" letters when a drug application is not approved.
Instead, it issues a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.