+ Regulatory
Gene Johnson | Mar 21, 2017

GlaxoSmithKline submits supplemental application to the FDA for its flu vaccine

GlaxoSmithKline (GSK) has submitted a supplemental biologics license application to the Food and Drug Administration to expand the use of its flu vaccine to patients 6 months and older.

Fluarix Quadrivalent is currently approved for immunization against influenza A subtype viruses and type B viruses in children age 3 and older, according to a GSK press release.

The application is response to a recent study on the effectiveness of Fluarix Quadrivalent in children 6 months through 35 months old and on two supportive studies.

The results of that recent study will be presented to the European Society for Paediatric Infectious Diseases at its annual meeting May 23-27 in Spain.

Organizations in this story

More News