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FDA Revokes Approval for Antiepileptic

Agency cites manufacturing quality problems

The FDA has revoked an approval issued in March to India's Sun Pharma Advanced Research Company Ltd. (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site.

The move comes as a setback to SPARC, the research arm of India's largest drugmaker, Sun Pharmaceutical Industries Ltd. According to Reuters, the drug, Elepsia XR (levetiracetam extended-release, SPARC) was its first to receive an FDA approval.

The company said in June it had been working "very aggressively" to find partners for the product. It had had "some advanced discussions" and aimed to launch the drug by the second half of fiscal 2016.

Analysts estimated modest sales of about $50 million annually from Elepsia XR. 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 12 years of age and older.

Most analysts saw the approval as positive mainly because it came despite the FDA having expressed concerns a year ago about manufacturing processes at the Halol plant. Sun Pharma had been working on fixing the issues the FDA outlined, and some analysts said the approval allayed fears of a possible adverse FDA action at Halol.

On Saturday, SPARC said the FDA issued it a Complete Response Letter in which it said "the compliance status of the manufacturing facility was not acceptable on the date of approval." It said Sun Pharma "has taken several corrective measures" to fix problems at the plant.

Source: Reuters; September 26, 2015

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