STN: BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Manufacturer: GlaxoSmithKline Biologicals, License #1617
- For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9), for use in infants 6 weeks to 24 weeks of age.
February 27, 2015 Approval Letter - Rotarix
To include product labeling to indicate that the diluent in oral applicators should be stored at 2-8°C or at controlled room temperature up to 25°C instead of the current recommendation for storage at 20-25°C.
May 1, 2014 Approval Letter - Rotarix
To include a summary of post-marketing surveillance data suggestive of an increased risk of intussusception in the 7 days following dose 2 of Rotarix.
November 27, 2013 Approval Letter - Rotarix
To change the product labeling in accordance with the guidance issued on March 11, 2013.
September 7, 2012 Approval Letter - Rotarix
To update the package insert and patient information to reflect the results from the final analysis of the Mexico PASS data.
June 8, 2012 Approval Letter - Rotarix
To update the package insert and patient package insert to reflect transmission data from Twins Transmission Study Rota-052.
February 24, 2011 Approval Letter - Rotarix
Updated package insert and patient package insert to include "history of intussusception" as a contraindication to vaccination.
January 13, 2011 Approval Letter - Rotarix
Revision: Update package insert to address latex hypersensitivity
September 17, 2010 Approval Letter - Rotarix
Revision: Update the package insert to include changes to the Warnings and Precautions section and Post-marketing Experience section of Adverse Reactions.
September 1, 2010 Approval Letter - Rotarix
Includes updates to the package insert and patient information labeling to reflect the presence of Porcine Circovirus Type-1 in the vaccine.
February 22, 2010 Approval Letter - Rotarix
Approval to revise the contraindications section in the Package Insert.
December 30, 2009 Approval Letter - Rotarix
Revision: To include a contraindication for demonstrated history of hypersensitivity to the vaccine or any components of the vaccine, in the Warning and Precautions section.
May 1, 2009 Approval Letter - Rotarix
Revision: To update the Prescribing Information.
February 12, 2009 Approval Letter - Rotarix
Revision: To include changes to your package insert and container/carton labels to move the phrase "Do not freeze; discard if frozen."
April 3, 2008 Approval Letter - Rotarix
Indication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks.
Summary Basis for Regulatory Action - Rotarix Approval History, Letters, Reviews, and Related Documents - Rotarix[ARCHIVED]
FDA Online Label Repository
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FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus[ARCHIVED]
Press Release: April 3, 2008
Update on Rotavirus Vaccine Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception
Questions and Answers, September 7, 2012