March 28, 2013 Approval Letter - ActHIB
Our STN: BL 103935/5295 & 103935/5296
Sanofi Pasteur SA
Attention: Joseph H. Quinn
Swiftwater, PA 18370
Dear Mr. Quinn:
We have approved your requests to supplements to your biologics license application for Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), ActHIB® to include changes to the package insert to the How Supplied section including unique/different NDC numbers for container, carton, and diluent and to include 2D Barcode for the container and diluent labels.
These supplements are approved for the following:
STN 103935/5295: approved for the unique/different NDCs on the container and carton labels and the addition of these NDCs to the “How Supplied” section of the package insert.
STN 103935/5296: approved for the 2D Barcodes on the diluent and container labels.
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).
Under 21 CFR 201.57(c) (18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10-point font.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. 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.
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)).
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