September 16, 2010 Approval Letter - BioThrax
Our STN: BL 103821/5207
Emergent BioDefense Operations Lansing Inc.
Attention: Jeffrey Smith
3500 N. Martin Luther King, Jr. Blvd.
Lansing, MI 48906
Dear Mr. Smith:
We have approved your request to supplement your biologics license application for Anthrax Vaccine Adsorbed, Injection, to include a proposed Patient Package Insert (PPI).
Under 21 CFR 201.57(f)(2), patient labeling must be reprinted at the end of the package insert and printed in a minimum of 10- point font.
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.
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.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling