Product Approval Information
Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: ROTARIX
Manufacturer: GlaxoSmithKline Biologicals, License #1617
STN: 125265/0
Approval Date: April 3, 2008
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Approval information/letter/labeling
Memorandum/Reviews
- Summary Basis for Regulatory Action
- Analysis of Rotarix Minimum Release Potency
- Bioresearch Monitoring Inspection Results
- BLA Filing Meeting Memo
- Categorical Exclusion under 21 CFR 25.31 (c)
- Clinical Review (PDF - 3.6 MB)
- Clinical Support for the Efficacy of Rotarix - Potency
- Concluding Review Memo/E-mail for Rota CMC
- Email Exchange between 1/22/2008 - 3/4/2008
- Executive Summary for the CMC Section of STN 125265/0
- Executive Summary Pharmacovigilance Review
- Final Review Memo
- Memo of Device Review (1/17/2008)
- Memo of Device Review (10/23/2007)
- Mid Cycle Review Meeting
- Monkey Neurovirulence Safety Testing of GSK Rotarix Vaccine
- Pharmacovigilance Plan in BLA Submission
- Potency Release Specifications - Internal Meeting Memo
- Recommendation for Consideration for Licensure of Rotavirus Vaccine
- Recommendations Regarding Request for Partial Waiver of Pediatric Studies
- Review Memorandum - Evaluation of Proposed Proprietary Name Rotarix
- Review Memo - CMC section
- Review Memo- GSK Building
- Review Memo for Amendments 13, 15, 16, 19, 24, and 29
- Review of Pertussis Clinical Serology
- Review of Responses Submitted by GlaxoSmithKline Biologicals to Issues on the Form FDA 483
- Review regarding Concomitant Administration
- Review of Vero Cell Banks used for Vaccine Production and Adventitious Agent Testing of Virus Seeds and Vaccine Human Rotavirus Vaccine (HRV)
- Rotavirus Diluent Review Memo
- Statistical Review
- Statistical Review and Evaluation
- STN 125265 Rotarix
- Toxicology Review
- Validation Report and Standard Operating Procedure (SOP) for Measurement of Total Antibody to Haemophilus Influenzae type b Capsular Polysaccharide PRP - Final Review Memo
- Validation Report and Standard Operating Procedure (SOP) for Measurement of Total IgG Antibody to Streptococcus pneumoniae Polysaccharides (PS) in Human Serum - Final Review Memo
Administrative Documents
Correspondence
- 3/31/2008 Email
- 3/28/2008 Email
- 3/9/2008 Email
- 3/7/2008 Email
- 3/5/2008 Email
- 2/15/2008 Email
- 1/23/2008 Email
- 1/8/2008 Email
- 11/6/2007 Email
- 6/5/2007 Email
- Fax
- 11/1/2007 Fax
- 4/1/2008 Telecon
- 3/31/2008 Telecon
- 3/17/2008 Telecon 1
- 3/17/2008 Telecon 2
- 3/10/2008 Telecon
- 2/29/2008 Telecon
- 1/14/2008 Telecon