Sun Pharma Advanced Research Company gets Complete Response letter from USFDA

For Latanoprost NDA

Sun Pharma Advanced Research Company (SPARC) announced that the U.S. 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 submitted a response to an earlier CRL it had received from the USFDA, wherein no additional preclinical or clinical data was required. 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.

This product is to be manufactured at SPIL's Halol facility and the USFDA has indicated that a satisfactory resolution of the cGMP deficiencies at this facility is a prerequisite for the final approval of Xelpros. SPARC had recently out-licensed this product to a subsidiary of Sun Pharmaceutical Industries.

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