Green Cross Corporation (Green Cross), a South Korean biopharmaceutical company, has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G for intravenous administration) intended for the treatment of primary immunodeficiency diseases.
The requests raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC). As the CRL did not cite efficacy or safety issues, Green Cross believes that these items can be addressed and is working for a timely response to the FDA. Green Cross remains committed to bringing IVIG-SN to the US market as a meaningful immune globulin product option.
A CRL is issue by the FDA's Center for Biologics Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the BLA in its current form.
Green Cross Corporation is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.