NEW DELHI, Dec 22: Sun Pharma Advanced Research Company today said the US health regulator has not approved its new drug application for Xelpros, a preservative-free eye drop.
“The company has received a Complete Response Letter (CRL) from USFDA for the new drug application (NDA) for Xelpros,” Sun Pharma Advanced Research Company (SPARC) said in a BSE filing.
A CRL is a communication from USFDA that informs companies that an application cannot be approved in its present form.
It further said, “The CRL references the recent inspection of the Sun Pharmaceutical Industries’ Halol manufacturing site by USFDA and indicates that satisfactory resolution of deficiencies identified during the inspection is required before final approval of Xelpros”.
Last year, SPARC had licensed the product to a subsidiary of Sun Pharma, it added.
Earlier this month, Sun Pharma said the US health regulator had made nine observations after the completion of inspection of its Halol facility in Gujarat.
The company is preparing responses to the observations, which will be submitted to USFDA within 15 business days.
Sun Pharma had been earlier issued a warning letter by USFDA for its Halol facility in December 2015. The letter followed inspection in September 2014 by FDA inspectors.
The company has been making efforts to make the Halol plant CGMP (current good manufacturing practices)-compliant again.
(PTI)
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