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October 20, 2014 Approval Letter - Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

October 20, 2014 Approval Letter - Adenovirus Type 4 and Type 7 Vaccine, Live, Oral

Our STN:  BL 125296/43                                                              

Teva Women’s Health, Inc.
Attention:  Sally Fedon                                 
41 Moores Road
P.O. Box 4011
Frazer, PA 19355

Dear Ms. Fedon:

We have approved your request to supplement your biologics license application for Adenovirus Type 4 and Type 7 Vaccine, Live, Oral manufactured at your Forest, VA, facility to revise the package insert to remove references to the Pregnancy Registry.

Please provide your final content of labeling in Structured Product Labeling (SPL) format.  In addition, please submit three original paper copies for carton and container final printed labeling.  All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.  Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.

You may 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. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

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)).

Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these change(s).

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

Sincerely yours,

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics               
Evaluation and Research

Attachment:  Approved Final Draft Labeling