Posted by Michael Wonder on 06 Jun 2017
BioCryst announces Rapivab paediatric sNDA acceptance
5 June 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has accepted for review the supplemental new drug application for a paediatric indication of Rapivab (peramivir injection), which was submitted in March 2017.
The application has been classified by the FDA as a priority review and has a Prescription Drug User Fee Act goal date for a decision by the end of September 2017.
Rapivab is being commercialised by Seqirus globally, excluding Japan, Taiwan, Korea and Israel. Seqirus is a leader in influenza prevention through the global supply of seasonal and pandemic influenza vaccines.
