Skip to Content

Rotarix Approval History

  • FDA approved: Yes (First approved April 3rd, 2008)
  • Brand name: Rotarix
  • Generic name: rotavirus vaccine, live attenuated
  • Dosage form: Oral Suspension
  • Company: GlaxoSmithKline
  • Treatment for: Prevention of Rotavirus Gastroenteritis

Rotarix (rotavirus vaccine live) is an oral, two-dose, live attenuated vaccine for the prevention of rotavirus gastroenteritis in children.

Development History and FDA Approval Process for Rotarix

Apr  4, 2008Approval FDA Approves Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus
Feb 20, 2008GSK Receives Favorable Recommendation by FDA Advisory Committee for Rotarix (Rotavirus Vaccine, Live, Oral)
Aug 14, 2007GlaxoSmithKline's Application for Rotarix is Accepted for Review bythe FDA
Jun 27, 2007AVANT's Partner, GlaxoSmithKline, Files Rotarix Application for U.S. Marketing Approval with the FDA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.