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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 22, 2009 Approval Letter - Pentacel

December 22, 2009

Our STN:  BL 125145/88

Sanofi Pasteur Limited
Attention: Joseph H. Quinn
1755 Steeles Avenue West
Toronto, Ontario July 13, 2009
Canada M2R 3T4

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine to revise the labeling to comply with the Physician’s Labeling Rule format.

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.

Sincerely yours,

--signature--

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

Attachment: Approved Final Draft Labeling

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002