STN: BLA 101094
Proper Name: Pneumococcal Vaccine, Polyvalent
Tradename: Pneumovax 23
Manufacturer: Merck & Co., Inc, License #0002
- PNEUMOVAX 23 is indicated for active immunization against pneumococcal disease caused by those pneumococcal types included in the vaccine in persons 50 years of age or older and persons greater than or equal to 2 years of age who are at increased risk for pneumococcal disease.
December 30, 2014 Approval Letter - Pneumovax 23
To include a 2D barcode on the single dose pre-filled syringe label.
May 30, 2014 Approval Letter - Pneumovax 23
To include the addition of a single dose pre-filled syringe presentation that will utilize a new pre-filled syringe filling line in building 38 of your West Point, Pennsylvania facility, and accompanying labeling changes.
October 27, 2011 Approval Letter - PNEUMOVAX 23
To allow the addition of information regarding concomitant administration with ZOSTAVAX® to the labeling and revise the labeling to comply with the Physician’s Labeling Rule (PLR).
Summary Basis for Regulatory Action - Pneumovax 23 - October 25, 2011(PDF - 66KB)
- January 21, 2011 Approval Letter -Pneumovax 23
Revised with changes to the package insert to update the Geriatric Use and the Adverse Reactions sections.
June 5, 2009 Approval Letter - PNEUMOVAX®23
Revision to Package Insert: To include the addition of language to update the package insert to reference current ACIP recommendations.
January 16, 2009 Approval Letter - Pneumovax 23
Revisions to Package Insert: Revisions include the addition of language to the Adverse Reactions section indicating that certain systemic events may be associated with local injection site reactions and modified text under ....
August 6, 2008 Approval Letter - Pneumovax 23
Labeling Change: To include the new term “Leukocytosis” in the Adverse Reactions section of the package insert.
Summary for Basis of Approval - PNEUMOVAX-23 - Pneumococcal Vaccine, PolyValent, June 30, 1983(PDF - 274KB)