October 5, 2011 Approval Letter - Recombivax
Our STN: BL 101066/5353
Merck Sharp & Dohme Corp.
Attention: Stella Reed, Ph.D., MPH
PO Box 1000, UG2D-68 North Wales, PA 19454-1099
Dear Dr. Reed:
We have approved your request to supplement your biologics license application for RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant) to revise the package insert to include the residual formaldehyde content of the vaccine in the Description section, and the term “uveitis” in the Adverse Reactions section.
Please provide your final content of labeling in Structured Product Labeling (SPL). 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.
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 changes.
We will include the 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