USFDA rejects Sun Pharma's Anti-Glaucoma Eyedrops
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In a setback to Sun Pharma, USFDA yesterday rejected its subsidiary's Sun Pharma Advanced Research Company's Application for its new anti-glaucoma eye drops.
The product is to be manufactured at Sun Pharmaceutical Industries' Halol facility and the USFDA has indicated that a satisfactory resolution of the current good manufacturing practice (cGMP) deficiencies at this facility is a prerequisite for the final approval of Xelpros, SPARC said.
"The US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its new drug application (NDA) for Xelpros, Latanoprost BAK-free eyedrops," SPARC Ltd said in a statement.
A CRL is a communication from the USFDA that informs companies that an application cannot be approved in its present form.
SPARC had recently out-licensed the product to a subsidiary of Sun Pharmaceutical Industries Ltd, it added.
"The US Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its new drug application (NDA) for Xelpros, Latanoprost BAK-free eyedrops," SPARC Ltd said in a statement.
A CRL is a communication from the USFDA that informs companies that an application cannot be approved in its present form.
SPARC had recently out-licensed the product to a subsidiary of Sun Pharmaceutical Industries Ltd, it added.
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