 "US FDA revokes approval for Sun Pharma's epilepsy drug")
The US Food and Drugs Administration (FDA) has withdrawn an approval granted to an anti-epileptic drug of Sun Pharma Advanced Research Company (SPARC) due to regulatory compliance issues at Sun Pharma's Halol plant. The company had earlier received a final approval from US FDA in March 2015 for this product and was evaluating several marketing partners for commercialisation.
"The USFDA has issued a Complete Response letter (CRL) to the company's new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg) rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval," SPARC said in a statement on September 25, 2015.
Elepsia XR is to be manufactured at Sun Pharma’s Halol facility. The company is working with USFDA in resolving the current good manufacturing practice (cGMP) deviations at the facility and has taken several corrective measures.
"The USFDA has issued a Complete Response letter (CRL) to the company's new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg) rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval," SPARC said in a statement on September 25, 2015.
Elepsia XR is to be manufactured at Sun Pharma’s Halol facility. The company is working with USFDA in resolving the current good manufacturing practice (cGMP) deviations at the facility and has taken several corrective measures.