Vaccines, Blood & Biologics

November 20, 2009 Approval Letter - ActHIB

November 20, 2009

Our STN: 103935/5191

Sanofi Pasteur Inc.
Attention: Joseph H. Quinn.
Discovery Drive
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.


Sincerely yours,

Wellington Sun, MD
Division of Vaccines and Related
Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

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