U.S. Food and Drug Administration (FDA) has issued a Complete Response letter (CRL) to Sun Pharma Advanced Research Company’s (SPARC’s) New Drug Application (NDA) for Latanoprost BAK-free eyedrops.
While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA.
SPARC believes that this additional information request from the FDA can be addressed on priority. SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
