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

RotaTeq - February 5, 2009 Approval Letter
Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent) Approval Letter (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 ®.
RotaTeq - April 30, 2008 Approval Letter
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®.
RotaTeq - September 28, 2007 Approval Letter
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.
RotaTeq - June 15, 2007 Approval Letter
Revised Labeling: To include changes to the package insert regarding Kawasaki Disease.
RotaTeq - February 3, 2006 Approval Letter
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.
RotaTeq - Clinical Review -Part 1 (PDF - 794KB)
RotaTeq - Clinical Review -Part 2 (PDF - 847KB)
RotaTeq - Questions and Answers
FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants
Press Release: February 3, 2006

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