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RotaTeq Approval History

  • FDA approved: Yes (First approved February 3rd, 2006)
  • Brand name: RotaTeq
  • Generic name: rotavirus vaccine, live, oral, pentavalent
  • Company: Merck & Co., Inc.
  • Treatment for: Rotavirus Gastroenteritis

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is an oral, three-dose vaccine given to infants between the ages of six to 32 weeks for the prevention of rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.

Development History and FDA Approval Process for RotaTeq

DateArticle
Feb  3, 2006Approval RotaTeq Approved - Merck & Co., Inc. - Treatment for Prevention of Rotavirus Gastroenteritis
Dec 14, 2005FDA Vaccines Advisory Committee Unanimously Agrees that Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of Rotateq, Merck's Investigational Vaccine for Rotavirus Gastroenteritis
Jun 29, 2005Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
Apr 11, 2005Merck Submits Biologics License Application to FDA for Rotateq, an Investigational Vaccine for Rotavirus

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