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

Related Hub content

    Your search did not contain any words. Please try again.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
mXm Medical Communications

mXm Medical Communications meets the needs of pharmaceutical marketers and medics who require a highly experienced, bespoke service from their...

Latest intelligence

Business in the USA
The pharma business environment in the US
Tighter regulations, more pricing controls and increased international competition will drive market improvements...
babylon virtual health service
VIDEO: Switching to a virtual health service
Ali Parsa, CEO and founder of babylon, discusses the benefits of conducting healthcare consultations via a smartphone...
Online Physician Communities
Is the pharma industry bad?
Surveys of doctors and the public suggest not...