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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 company had earlier also received a CRL from the USFDA for the product.
SPARC had submitted a response to an earlier CRL it had received from the USFDA, wherein no additional preclinical or clinical data was required, it said.
"While the USFDA has accepted the clarifications and changes to the labeling, SPARC has now received another CRL from the USFDA seeking minor changes to the proposed labeling. SPARC hopes to address these requirements soon," it added.
Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication using Swollen Micelle Microemulsion (SMM) technology.
Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate Ocular Surface Disease (OSD).
