Department of Health & Human Services
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
Our STN: BL 125122/636
Merck & Co., Inc.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Koser:
We have approved your request to supplement your biologics license application for Rotavirus Vaccine, Live, Oral, Pentavalent, 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 has also been updated accordingly.
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.
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.
We will include information contained in the above-referenced supplement in your biologics 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