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Rotarix FDA Approval History

FDA Approved: Yes (First approved April 3, 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 timeline for Rotarix

Nov  7, 2022Approval FDA Approves New Fully Liquid Presentation of GSK’s Rotarix Vaccine to Prevent Gastroenteritis Caused by Rotavirus
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

Further information

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