Pfizer approved for Prevenar 13 USPI to include expanded use

February 4, 2014

The FDA stated in an approval letter posted to its website that Pfizer's Wyeth unit was approved to supplement its biologics license application for Prevnar 13 to include text in the U.S. Prescribing Information, or USPI, for use in preterm infants under 37 weeks of gestational age.