Sun Pharma Advanced Research Company (SPARC) has received Complete Response letter (CRL) from U.S. Food and Drug Administration (USFDA) to its New Drug Application (NDA) for Xelpros, Latanoprost BAK-free eyedrops. The company has 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, company has now received another CRL from the USFDA seeking minor changes to the proposed labeling. The company 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 (SPIL).
Sun Pharma Advanced Research Company is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
