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February 22, 2010 Approval Letter - Rotarix
Attention: Benedicte T. Dupasquier, PharmD
2301 Renaissance Boulevard
P.O. Box 61540
Dear Dr. Dupasquier:
We have received your February 3, 2010, supplement to your biologics license application for Rotavirus Vaccine, Live, Oral, to revise the package insert, to revise the Contraindications section to include infants with Severe Combined Immunodeficiency Disease (SCID) because of post-marketing reports describing severe gastroenteritis and vaccine viral shedding in these patients. The patient package insert will also be updated accordingly.
This Supplement has been reviewed under STN 125265/256 and is approved effective this date.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.
This information will be included in your License Application File.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling