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Vaccines, Blood & Biologics

May 4, 2011 Approval Letter - Recombivax HB

Our STN: BL 101066/5351

Merck Sharp & Dohme Corp.
Attention: Stella Reed, Ph.D., MPH
PO Box 1000, UG2D-68
North Wales, PA 19454-1099

Dear Dr. Reed:

We have approved your request to supplement your biologics license application for Hepatitis B Vaccine (Recombinant) Recombivax HB® to revise labeling to address latex hypersensitivity in the Precautions section of the package insert. 

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format, as well as three original paper copies. 

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

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

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