Our STN: BL 125122/1133
Merck, Sharp & Dohme Corp.
Attention: Paul L. Koser, Ph.D.
P.O. Box 1000
North Wales, PA 19454-1099
Dear Dr. Koser:
Please refer to your Supplemental Biologics License Application (sBLA), dated June 3, 2013, received June 3, 2013, submitted under section 351 of the Public Health Service Act for Rotavirus Vaccine, Live, Oral, Pentavalent.
We also refer to our letter dated May 10, 2013, notifying you, under Section 505(o)(4) of the
Federal Food, Drug, and Cosmetic Act (FDCA), of new safety information that we believe should be included in the labeling for Rotavirus Vaccine, Live, Oral, Pentavalent. This information pertains to an increased risk of intussusception after the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent.
This sBLA provides for revisions to the labeling for Rotavirus Vaccine, Live, Oral, Pentavalent, consistent with our May 10, 2013, Safety Labeling Change Notification Letter.
We have approved your sBLA for Rotavirus Vaccine, Live, Oral, Pentavalent, to include new safety information on the risk of intussusception in the package insert and patient package insert.
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.
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.
As soon as possible, but no later than 14 days from the date of this letter, 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 materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement, including any new safety information [21 CFR 601.12(a)(4)]. The revisions to your promotional materials should include prominent disclosure of the important new safety information that appears in the revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent to comply with 21 CFR 601.12(a)(4) to the address above.
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)).
Also within 14 days, 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 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 Biologic
Evaluation and Research