Sun Pharma Advanced Research Company’s (SPARC) licensing partner -- Ocuvex Therapeutics Inc. has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (USFDA) for the PDP-716 New Drug Application (NDA). The CRL was issued due to inspection findings at the finished product manufacturing facility. The USFDA did not raise any other issues with the PDP-716 NDA.
Sun Pharma Advanced Research Company is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery.
