Memorandum/Reviews

• Summary Basis for Regulatory Action - Rotarix
• Analysis of Rotarix Minimum Release Potency
• Bioresearch Monitoring Inspection Results - Rotarix
• BLA Filing Meeting Memo - Rotarix
• Categorical Exclusion under 21 CFR 25.31 (c) - Rotarix
• Clinical Review for STN 125265/0 Rotarix: Rotavirus Vaccine, Live, Oral (PDF - 4.5MB)
• 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 - Rotarix
• Executive Summary for the CMC Section of STN 125265/0 - Rotarix
• Executive Summary Pharmacovigilance Review - Rotarix
• Final Review Memo - Rotarix
• Memo of Device Review (1/17/2008) - Rotarix
• Memo of Device Review (10/23/2007) - Rotarix
• Mid Cycle Review Meeting - Rotarix
• Monkey Neurovirulence Safety Testing of GSK Rotarix Vaccine
• Pharmacovigilance Plan in BLA Submission - Rotarix
• Potency Release Specifications - Internal Meeting Memo - Rotarix
• Recommendation for Consideration for Licensure of Rotavirus Vaccine - Rotarix
• Recommendations Regarding Request for Partial Waiver of Pediatric Studies - Rotarix
• Review Memorandum - Evaluation of Proposed Proprietary Name Rotarix
• Review Memo - CMC section - Rotarix
• Review Memo - GSK Building - Rotarix
• Review Memo for Amendments 13, 15, 16, 19, 24, and 29 - Rotarix
• Review of GSK - Labeling - Rotarix
• Review of Pertussis Clinical Serology - Rotarix
• Review of Responses Submitted by GlaxoSmithKline Biologicals to Issues on the Form FDA 483 - Rotarix
• Review Regarding Concomitant Administration - Rotarix
• Review of Vero Cell Banks used for Vaccine Production and Adventitious Agent Testing of Virus Seeds and Vaccine Human Rotavirus Vaccine (HRV) - Rotarix
• Rotavirus Diluent Review Memo - Rotarix
• Statistical Review - Rotarix
• Statistical Review and Evaluation - Rotarix
• 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
• Validation Report and Standard Operating Procedure (SOP) for Measurement of Total IgG Antibody to Streptococcus pneumoniae Polysaccharides (PS) in Human Serum

Administrative Documents

• Officer/Employee List - Rotarix

Correspondence

• 3/31/2008 Email - Rotarix
• 3/28/2008 Email - Rotarix
• 3/9/2008 Email - Rotarix
• 3/7/2008 Email - Rotarix
• 3/5/2008 Email - Rotarix
• 2/15/2008 Email - Rotarix
• 1/23/2008 Email - Rotarix
• 1/8/2008 Email - Rotarix
• 11/6/2007 Email - Rotarix
• 6/5/2007 Email - Rotarix
• Fax - Rotarix
• 11/1/2007 Fax - Rotarix
• 4/1/2008 Telecon - Rotarix
• 3/31/2008 Telecon - Rotarix
• 3/17/2008 Telecon 1 - Rotarix
• 3/17/2008 Telecon 2 - Rotarix
• 3/10/2008 Telecon - Rotarix
• 2/29/2008 Telecon - Rotarix
• 1/14/2008 Telecon - Rotarix

Contact FDA