Fast-track designation granted in 2006; positive phase III data reported 7/09; In 10/09 FDA issued an emergency use authorization (EUA) for the investigational anti-viral drug intravenous (i.v.) peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital; Japan files sNDA in pediatric patients 2/10; approved in Korea (8/10)
Brand Rapiacta (brand name in Japan) Generic peramivir
Company name BioCryst, Shionogi Product type Non-speciality
Therapeutic category Antivirals Key uses seasonal influenza
Other Uses N/A Drug Class neuraminidase inhibitor
Dosage From IV and IM Expected Approval 2011-Q4
FDA Filing N/A Last Update date August 18,2010
Link to pipeline report
Link to news article
Link to clinicaltrials.gov
Link to press releases