Merck: FDA Extends PDUFA Date Of SBLA For VAXNEUVANCE - Quick Facts

(RTTNews) - Merck (MRK) announced FDA has extended the PDUFA date of the supplemental biologics license application for VAXNEUVANCE in infants and children to July 1, 2022. Merck said the FDA requested additional analyses of data from the pediatric studies, which it has submitted to the FDA.

"We are confident in the strength of the data from our pediatric studies with VAXNEUVANCE and will continue to work expeditiously with the FDA to bring this important vaccine forward to infants and children in the United States as soon as possible," said Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.