ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.
06/04/2007 - The Biologics License Application (BLA) for Rotavirus Vaccine, Live, Oral (ROTARIX®) from GlaxoSmithKline Biologicals (GSK) was received by CBER.
06/2000 - GSK had filed an Investigational New Drug Application (IND) under which an initial Phase 2 study had been conducted in the U.S.
09/2006 - Pre-BLA meeting was held.
04/03/2008 - PDUFA Goal Date
11/12/2019 - FDA approval date
The Vaccines and Related Biological Products Advisory Committee meeting took place on February 20, 2008. The committee voted unanimously regarding the adequacy of the efficacy of the vaccine and all except one member voted in favor of the adequacy of the safety data to support the licensure of ROTARIX.