May 30, 2014 Approval Letter - Pneumovax 23

Our STN:   BL 101094/5911                    

Merck Sharp & Dohme Corp.

Attention: C. Abeygunawardana

P.O. Box 1000, UG2D-68

North Wales, PA 19454-1099

Dear Mr. C. Abeygunawardana:

We have approved your request to supplement your biologics license application for Pneumococcal Vaccine, Polyvalent (Pneumovax23®) to include the addition of a single dose pre-filled syringe presentation that will utilize ---------------------------(b)(4)----------------------------- your West Point, Pennsylvania facility, and accompanying labeling changes.

The dating period for Pneumovax23® in pre-filled syringes shall be 24 months from the date of formulation when stored at 2 – 8 ºC.

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 and FDA Form 2567 as appropriate.

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, 10903 New Hampshire, Avenue, Building 71, Silver Spring, MD 20993. 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 information contained in the above-referenced supplement in your biologics license application files.

                                                                                   Sincerely yours,

                                                                                    Jay E. Slater, M.D.

                                                                                    Director

                                                                                    Division of Bacterial, Parasitic

                                                                                     and Allergenic Products

                                                                                    Office of Vaccines

                                                                                     Research and Review

                                                                                    Center for Biologics

                                                                                     Evaluation and Research