US FDA rescinds approval for Sun Pharma's epilepsy drug Elepsia XR

The US Food and Drug Administration (US FDA) has revoked an earlier approval to Sun Pharma Advanced Research Company Ltd (SPARC) to market its new drug for seizures, citing compliance status of its production facility at Halol in India.

The drug, Elepsia XR, received an FDA approval, in March 2015, was ready for commercial launch and therefor the US FDA move comes as a setback to SPARC, the research arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd.

SPARC has now received a complete response letter (CRL) form the US FDA for its new drug application for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg).

SPARC, after receiving a final approval from USFDA in March 2015 for this product, was evaluating several marketing partners for commercialisation.

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, the company stated in a release.

Under new regulations, USFDA's Center for Drug Evaluation and Research (CDER) no longer issues "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER 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. 

SPARC had said it would produce the drug, an adjunct treatment for partial onset seizures in epilepsy patients of 12 years and older, at Sun Pharma's plant at Halol, in Gujarat.

Most analysts had seen the approval as positive mainly because it came despite the FDA having expressed concerns a year ago about manufacturing processes at the Halol plant.

Analysts had estimated modest sales of about $50 million annually from Elepsia XR.