SPARC receives CRL from US FDA for Latanoprost NDA

Read Article

The product will be manufactured at SPIL’s Halol facility

Sun Pharma Advanced Research Company (SPARC) announced that the US Food and Drug Administration (US FDA) 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 US FDA, wherein no additional preclinical or clinical data was required.  While the US FDA has accepted the clarifications and changes to the labelling, SPARC has now received another CRL from the US FDA seeking minor changes to the proposed labelling. SPARC hopes to address these requirements soon.

The product is to be manufactured at SPIL’s Halol facility and the US FDA 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 Ltd (SPIL).

Complete Response letterSPARCUS FDA