Global Drugs & Biologics Update

February 24, 2015


North America

United States

FDA – CBER – Center for Biologics

Approvals/Clearances

Approvals updated

The updated approvals include the 2015 approvals of biologicals, noteworthy supplements, biological device licenses, as well as Sanofi’s supplement for Acellular Pertussis Vaccine Adsorbed (Adacel),GSK&rsquo supplement for HPV vaccine (Cervarix), MSD’s supplement for Grastek, and MedImmune&rsquo supplement for intranasal flu vaccine (FluMist).

2015 Biological Approvals

2015 Biological License Application Approvals

2015 Biological License Application Supplement Noteworthy Approvals

2015 Biological Device Application Approvals

February 11, 2015 Approval Letter - Adacel

February 13, 2015 Approval Letter - CERVARIX

February 13, 2015 Approval Letter - FluMist Quadrivalent

February 13, 2015 Approval Letter - GRASTEK

Close this Window