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FDA withdraws approval for Sun Pharma’s epilepsy drug

Published on 29/09/15 at 09:55am
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Manufacturing problems at Sun Pharma’s production site has led the FDA to revoke the company’s approval for Elepsia XR for seizures.

The drug had been the first Sun Pharma drug to earn approval from the FDA when it was approved in March.

The development is a setback to Sun Pharma’s Advanced Research Company Ltd (SPARC), the research arm of Sun Pharma, which is India's largest drugmaker and the world’s fifth largest manufacturer of specialty generics. Elepsia XR, an extended-release form of levetiracetam, was predicted by analysts to generate sales of around $50 million a year.

In 2014 the FDA expressed concerns about manufacturing processes at the company’s manufacturing plant in Halol, India. Sun Pharma says it had been working on fixing the issues the FDA outline, and in June the company said it had been working to find partners for the product and had ‘some advanced discussions’, aiming to launch the drug by the second half of 2016.

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.

Yasmita Kumar

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