GlaxoSmithKline submits final application for approval of Cervarix
March 31st, 2009 joshua
GlaxoSmithKline has submitted the paperwork necessary as part of the final process of getting its cervical cancer vaccine, Cervarix, approved by the Food and Drug Administration.
The FDA is expected to decide on whether Cervarix will be available in the U.S. after it reviews GSK’s latest data. This would be the first cervical cancer vaccine since the approval of Merck’s Gardasil, which has been pestered by reports of adverse reactions from girls getting the injections.
Cervarix is already available in more than 90 countries worldwide.
The biggest concern with Gardasil is the theory that it was rushed to the U.S. market and wasn’t properly run through all the clinical trial steps.
