YONGIN, South Korea I November 23, 2016 I Green Cross Corporation (Green Cross) (006280.KS), a South Korean biopharmaceutical company, today announced that it 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 U.S. 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.
About Green Cross Corporation
Green Cross Corporation is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, Green Cross is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for nearly half a century.
SOURCE: Green Cross
Post Views: 30
YONGIN, South Korea I November 23, 2016 I Green Cross Corporation (Green Cross) (006280.KS), a South Korean biopharmaceutical company, today announced that it 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 U.S. 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.
About Green Cross Corporation
Green Cross Corporation is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, Green Cross is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for nearly half a century.
SOURCE: Green Cross
Post Views: 30
