STN: BL 125122
Proper Name: Rotavirus Vaccine, Live, Oral, Pentavalent
Manufacturer: Merck & Co, Inc, License #0002
- For prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks.
June 13, 2013 Approval Letter - RotaTeq
To include new safety information on the risk of intussusception in the package insert and patient package insert
December 21, 2012 Approval Letter - RotaTeq[ARCHIVED]
To include changes to the package insert and patient package insert to reflect post-marketing reports of anaphylaxis and angioedema.
July 8, 2011 Approval Letter - RotaTeq[ARCHIVED]
To update the package insert to include a contraindication for “history of intussusception” and for a corresponding revision to the patient package insert to update the section “Who should not receive RotaTeq.”
Summary Basis for Regulatory Action ) RotaTeq(PDF - 227KB)
April 8, 2011
April 8, 2011 Approval Letter-RotaTeq[ARCHIVED]
To include changes to the package insert regarding results of a post marketing safety study (Study 019).
March 18, 2011 Approval Letter - RotaTeq
To update the package insert regarding WAES reports of administration of higher than recommended doses.
September 7, 2010 Approval Letter - RotaTeq[ARCHIVED]
Includes changes to the package insert regarding transmission of vaccine virus strains to non-vaccinated contacts.
September 1, 2010 Approval Letter - RotaTeq[ARCHIVED]
Includes update to the package insert to reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine.
December 23, 2009 Approval Letter - RotaTeq[ARCHIVED]
Includes revisions to the contraindications section for infants with Severe Combined Immunodeficiency Disease (SCID) because of post-marketing reports describing severe gastroenteritis and vaccine viral shedding in these patients.
February 5, 2009 Approval Letter - RotaTeq[ARCHIVED]
To update the Patient Product Information and Prescribing Information.
September 5, 2008 Approval Letter - Rotateq[ARCHIVED]
Revised Labeling: Include pertussis immune response data from the Rotavirus Efficacy and Safety Trial (REST) to support concomitant use of DTaP with RotaTeq ®.
April 30, 2008 Approval Letter - RotaTeq[ARCHIVED]
Revised Labeling: Include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq®.
September 28, 2007 Approval Letter - RotaTeq[ARCHIVED]
Revised Labeling: Include the addition of G9 P1A Serotype case reduction in the "Clinical Studies" section of the package insert, and revisions of the label in the Physician's Labeling Rule format.
June 15, 2007 Approval Letter - RotaTeq[ARCHIVED]
Revised Labeling: To include changes to the package insert regarding Kawasaki Disease.
Information Pertaining to Labeling Revision for RotaTeq
June 15, 2007
FDA Public Health Notification: Information on RotaTeq and Intussusception[ARCHIVED]
February 13, 2007
February 3, 2006 Approval Letter - RotaTeq
Indication: Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks.
Clinical Review Part 1 - RotaTeq(PDF - 794KB) [ARCHIVED] Clinical Review Part 2 - RotaTeq(PDF - 847KB) [ARCHIVED]
RotaTeq (Rotavirus Vaccine) Questions and Answers[ARCHIVED] FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants[ARCHIVED]
Press Release: February 3, 2006
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.
Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination
March 16, 2007 - Centers for Disease Control and Prevention