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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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,
/signature/

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