US FDA rejects Sun epilepsy drug due to ongoing problems at Halol plant

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Active pharmaceutical ingredient, Pharmaceutical drug, Food and drug administration

The US FDA has refused to reapprove Sun Pharma Advanced Research LTD’s epilepsy drug Elepsia XR (levetiracetam) citing problems at its plant in Halol, India.

The Sun unit announced its receipt of a complete response letter (CRL) in a Bombay Stock Exchange (BSE) filing​ last week.

The firm explained that “satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Elepsia XRTM can be granted​.”

Sun has been working to address problems at the Halol site – where the active pharmaceutical ingredient (API) for Elepsia is made – since 2014​ when a US Food and Drug Administration (FDA) team found a number of shortcomings.

Initially, Sun appeared to make some progress, winning US FDA approval for Elepsia in March 2015​.

However, the following September​ the agency reversed its decision explaining – in a letter published in December 2015​ – that Sun had still not addressed the problems at Halol.

A subsequent inspection of the facility in November and December last year​ earned Sun a second Form 483 detailing nine new problems.

Elepsiahad been earmarked for launch in the US in the second half of 2016 according to a business update​ in Jul7 2015. The drug was the first SPARC drug approved by the US Food and Drug Administration (FDA).

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