Please login to the form below

Not currently logged in
Email:
Password:

GSK submits two new flu vaccines for regulatory approval

Seeks licences for quadrivalent influenza vaccine and pandemic influenza vaccine

GlaxoSmithKline (GSK) has filed two new influenza vaccines for regulatory approval.

Its quadrivalent influenza vaccine, which has yet to be approved in its first market, has been submitted to the US Food and Drug Adminstration (FDA) and the European Medicines Agency (EMA).

GSK is seeking approval for the vaccine to be used in adults and children from three years of age against influenza disease caused by influenza virus types A and B that are contained in the vaccine.

The pharma company submitted a supplemental Biologics License Application to the FDA and filed a new application to the EMA.

Pandemic flu vaccine

Meanwhile, GSK has also submitted its H5N1 pandemic flu vaccine to the FDA for use in adults “as directed by the US Government”.

GSK's H5N1 influenza vaccine programme was supported by a development contract with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services.

That vaccine was approved in March, 2011 in Europe, where it is marketed under the brand name Pumarix and GSK's biologics unit has a five-year marketing authorisation from the European Commission.

6th March 2012

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Aptus Health

Aptus Health is dedicated to advancing health engagement. The company offers end-to-end digital health engagement solutions spanning all areas of...

Latest intelligence

How digital content is helping physicians curb the opioid abuse epidemic
By Stephen Smith, PA, MDE...
SEO for the healthcare industry
Gaining online visibility in any disease area remains a challenge for marketers...
Junior Doctor contracts – PR winners and losers
GCI Health's Caroline Howley on who's winning the PR battle around the junior doctors' strike....

Infographics