December 11, 2008 Approval Letter
December 11, 2008
Our STN: BL 103821-5080
Attn: David Willis, Ph.D.
Emergent BioDefense Operations Lansing Inc.
3500 N. Martin Luther King Jr. Blvd
Lansing , Michigan 48906
Dear Dr. Willis:
We have approved your request to supplement your biologics license application for Anthrax Vaccine Adsorbed (BioThrax®) to include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular. Anthrax Vaccine Adsorbed is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide content of labeling in Structured Product Labeling format. Please provide a PDF-format electronic copy as well as original paper copies (three for circulars and three for other labels).
In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by FDA Form 2253. 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 submitted data to support such claims to us and received CBER approval for such claims.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. We are waiving the pediatric study requirement for this application because the necessary studies are impossible or impracticable because the pediatric population is not under high risk conditions for this disease to get pre-exposure prophylaxis.
We acknowledge your statement in our teleconference of 10 December 2008 that you will request of CDC to submit the final Clinical Study Report for Protocol AVA 000 containing the safety and immunogenicity responses for the 12 and 18 month vaccine administration time points to their IND when it is available.
We also acknowledge your statement regarding establishment of a pregnancy registry to prospectively collect data on spontaneously-reported exposures to Biothrax ® during pregnancy and your intent to address elements found in FDA’s Guidance for Industry on Establishing Pregnancy Exposure Registries (9/2/2002) (http://www.fda.gov/cber/gdlns/pregexp.htm). These data may be used to support future labeling changes.
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 Draft Labeling