STN: BL 125265
Proper Name: Rotavirus Vaccine, Live, Oral
Manufacturer: GlaxoSmithKline Biologicals
- 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.
April 25, 2016 Approval Letter - Rotarix(PDF - 28KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
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[ARCHIVED]
To change the product labeling in accordance with the guidance issued on March 11, 2013.
September 7, 2012 Approval Letter - Rotarix[ARCHIVED]
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[ARCHIVED]
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[ARCHIVED]
Updated package insert and patient package insert to include "history of intussusception" as a contraindication to vaccination.
January 13, 2011 Approval Letter - Rotarix[ARCHIVED]
Revision: Update package insert to address latex hypersensitivity
September 17, 2010 Approval Letter - Rotarix[ARCHIVED]
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[ARCHIVED]
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[ARCHIVED]
Approval to revise the contraindications section in the Package Insert.
December 30, 2009 Approval Letter - Rotarix[ARCHIVED]
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[ARCHIVED]
Revision: To update the Prescribing Information.
February 12, 2009 Approval Letter - Rotarix[ARCHIVED]
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
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus[ARCHIVED]
Press Release: April 3, 2008
Update on Rotavirus Vaccine[ARCHIVED] Update: Information on Rotarix - Labeling Revision Pertaining to Intussusception
Questions and Answers, September 7, 2012