Product Approval Information

Proper Name: Rotavirus Vaccine, Live, Oral, Pentavalent
Tradename: RotaTeq
Manufacturer: Merck & Co., Inc, License #0002

Label (PDF - 157 KB)
Patient Information (PDF, 64 KB)

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Date: September 5, 2008
Revised Labeling: Include pertussis immune response data from the Rotavirus Efficacy and Safety Trial (REST) to support concomitant use of DTaP with RotaTeq ®.
September 5, 2008 Approval Letter

Date: April 30, 2008
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®
April 30, 2008 Approval Letter

Date: September 28, 2007
Revised Labeling: Include the addition of G9 P1A[8] Serotype case reduction in the "Clinical Studies" section of the package insert, and revisions of the label in the Physician's Labeling Rule format
September 28, 2007 Approval Letter

Date: June 15, 2007
Revised Labeling: To include changes to the package insert regarding Kawasaki Disease
June 15, 2007 Approval Letter

Date: February 3, 2006
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
February 3, 2006 Approval Letter
Clinical Review -Part 1 (PDF 793 KB)
Clinical Review -Part 2 (PDF 848 KB)
Questions and Answers

Important Product Information

Information Pertaining to Labeling Revision for RotaTeq - June 15, 2007
CDC Information Pertaining to RotaTeq - June 15, 2007

Postmarketing Monitoring of Intussusception After RotaTeq Vaccination --- United States, February 1, 2006--February 15, 2007 (MMWR) - March 16, 2007

FDA Public Health Notification: Information on RotaTeq and Intussusception - February 13, 2007

Updated: April 30, 2008