Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has delayed the approval of Pfizer's supplemental biologics license application (sBLA) of pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein] (Prevnar 13).
Subscribe to our email newsletter
Prevnar 13 is indicated for active immunization for the prevention of pneumococcal disease in adult patients aged 50 and older.
The FDA has extended the review period till January 2012.
The agency will review additional data from two studies which are submitted by Pfizer to support the sBLA, in the extended time period.
Pfizer Vaccine Research chief scientific officer Emilio Emini said they are working closely with the FDA on its review.
"We remain confident that our application supports the approval of Prevnar 13 in adults aged 50 and older," Emini said.