www.fdanews.com/articles/179428-gsk-gets-fda-approval-for-expanded-flulaval-indication
GSK Gets FDA Approval for Expanded FluLaval Indication
November 23, 2016
GSK announced it has gained approval from the FDA’s CBER expanding the indication for FluLaval Quadrivalent (influenza vaccine) to include use in children 6 months and older.
The sBLA was based on one phase III study and three supportive clinical studies conducted in children 6 months through 35 months of age.