US FDA denies approval to sell Sun Pharma’s epilepsy drug

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 had received a final approval from the USFDA in March this year for the product and it was evaluating several marketing partners for the product. Parent Sum Pharma fell 3.79 per cent to touch Rs 857.50.

Under the USFDA website, complete response letters are issued when communicating a decision to a drug company that its new drug application or abbreviated new drug application to market a new or generic drug will not be approved in its present form. The development may lead to disruptions in maintaining supply commitments and impact approvals for key drugs in the pipeline, analysts said. Analysts say that Halol is Sun Pharma’s flagship facility and USFDA clearance remains the most important catalyst for Sun Pharma in the near term.

SPARC had said it would produce the drug at Sun Pharma’s Halol plant, in Gujarat, as an adjunct treatment for partial onset seizures in epilepsy patients of 12 years and older. This Mumbai based giant is working out with USFDA to resolved this matter. However, it is indicative of the fact that the companies Halol facilities will take time to resolve, though company has indicated that it is taking corrective actions for rectifying the same.