November 20, 2009
Our STN: 103935/5191
Sanofi Pasteur Inc.
Attention: Joseph H. Quinn.
Swiftwater, PA 18370
Dear Mr. Quinn:
We have approved your request to supplement your biologics license application for
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), ActHIB®, to include changes to
the package insert regarding formaldehyde levels.
Please submit all final printed labeling at the time of use and include implementation information
on FDA Form 356h. Please provide a PDF-format electronic copy.
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, MD
Division of Vaccines and Related
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research