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US Approval Delay For Green Cross But Long Term Strategy Intact

 
• By Jung Won Shin

Green Cross has hit a bump in its journey to commercialize an immunoglobulin product in the US, but analysts say the approval delay will not be a significant obstacle to its longer term North American strategy.

The US FDA has issued a complete response letter (CRL) on Green Cross Corp.'s biologics license application for I.V.-Globulin SN (IVIG-SN), a human immunoglobulin G for intravenous administration, which although set to delay an approval is not expected by analysts to exact a serious toll on the South Korean company's North American business plans.

The plasma-derived product is administered to protect the body against infection. Green Cross's BLA, filed in November 2015, was intended to secure approval for the treatment of primary immunodeficiency diseases...

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