FDA issues a Complete Response Letter to Green Cross Corporation for IVIG-SN (human normal immunoglobulin G for intravenous administration) a treatment of primary immunodeficiency diseases.
Green Cross Corporation a South Korean biopharmaceutical company, announced that it has received a Complete Response Letter (CRL) from the 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 U.S. market as a meaningful immune globulin product option.
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