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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 5, 2010 Approval Letter - ACAM2000

Our STN: 125158/84

Sanofi Pasteur Biologics Co.
Attn: Mr. Joseph H. Quinn
38 Sidney Street
Cambridge, MA 02139

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Smallpox
(Vaccinia) Vaccine, Live, ACAM2000® to change the package insert, carton, vial, container and medication guide labeling for administrative changes and/or correction of inadvertent errors.  

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.

Please submit two copies of your final advertising and promotional labeling at the time of initial dissemination, accompanied by a Form FDA 2253, to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448.

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 or substantial clinical experience to support such claims
[21 CFR 202.1(e)(6)].

We will include information contained in the above-referenced supplement in your biologics license application files.

Sincerely yours,

/signature/                                                                       
Wellington Sun, M.D.
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