2024 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

Table showing 2024 Biological License Application Approvals">2024 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
CAPVAXIVE
Pneumococcal 21-valent Conjugate Vaccine
Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. 125814/0 Merck Sharp & Dohme LLC
P.O. Box 1000 UG2D-68
North Wales, PA 19454-2505