GSK: FDA delays approval for pandemic vaccine

The newest pandemic influenza vaccine developed by GlaxoSmithKline (NYSE: GSK) has been delayed in receiving approval.

GSK, which maintains its North American headquarters in RTP, said Monday that the U.S. FDA was delaying approval, having delivered a “complete response letter.”

A Complete Response letter is issued by FDA when a Prescription Drug User Fee Act (PDUFA) action date nears and additional review time is needed prior to approval,” GSK said. “In this case, the Complete Response letter was triggered due to an administrative matter that has recently been rectified.”

The company and the FDA “are actively working together to complete the review in a timely manner,” GSK added. 

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