Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Sanofi Pasteur submits supplemental A(H1N1) vaccine application

Sanofi Pasteur submits supplemental A(H1N1) vaccine application

7th August 2009

Sanofi Pasteur has submitted a supplemental application to the Food and Drug Administration (FDA) for the licensure of its A(H1N1) monovalent vaccine.

The submission of the application follows recommendations by the body to evaluate the vaccines under the same regulatory process it uses to approve new viral strains contained in the annual seasonal influenza vaccines.

Commenting on the submission, Wayne Pisano, president and chief executive of Sanofi Pasteur, explained that it is consistent with the company’s commitment to working with public health officials to produce a vaccine to combat the A(H1N1) 2009 virus.

He added: “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”

Last month, Sanofi Pasteur welcomed the European Medicines Agency Committee for Medicinal Products for Human Use’s confirmation of the safety of the firm’s Lantus (insulin glargine [rDNA] injection) therapy.

We currently have 6 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.