Wyeth's Prevnar 13 gets priority review status

Wyeth's Prevnar 13 gets priority review statusAccording to Wyeth's, FDA gave priority review status to Wyeth Pharmaceuticals' biologic license application for its Prevnar 13 infant vaccine.

Prevnar 13 is designed to protect infants against 13 serotypes, or forms, of a bacterium called streptococcus pneumoniae (pneumococcus) that can cause illness such as ear infections, pneumonia, bloodstream infections and meningitis.

FDA gives priority review designation to those products that, if approved, would provide a significant therapeutic or public health advancement.

Usually FDA takes its decision in 10 to 12 months however with priority review status the U. S. Food and Drug Administration will make its decision regarding the approval within six months.