"The US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to the company’s new drug application (NDA) for Elepsia XR," Sun Pharma Advanced Research Company (SPARC) said in a statement.
     
The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialisation, it added.
     
"However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval," it said.
     
Elepsia XR is to be manufactured at Sun Pharmaceutical Industries’s Halol facility. The Mumbai-based drug major is working with USFDA in resolving the current good manufacturing practice(cGMP) deviations at the facility and has taken several corrective measures.
    
Under new regulations, USFDA’s Center for Drug Evaluation and Research (CDER) no longer issues 'approvable' or 'not approvable' letters when a drug application is not approved.
     
Instead, CDER issues a 'complete response' letter at the end of the review period to let a drug company know of the agency’s decision on the application.

 

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