Licensed vaccine
ABRYSVO
FDA-licensed vaccine · Pfizer Inc. · STN 125769; 125768
Key facts
| Trade name | ABRYSVO |
|---|---|
| Proper name | Respiratory Syncytial Virus Vaccine |
| Manufacturer | Pfizer Inc. |
| Submission tracking number (STN) | 125769; 125768 |
| FDA product areas | Biologics |
| Recent FDA documents | January 6, 2025 Approval Letter - ABRYSVO (125769/388), October 22, 2024 Approval Letter - ABRYSVO (STN125769/225), August 30, 2024 Approval Letter - ABRYSVO (STN 125769/3), July 29, 2024 Approval Letter - ABRYSVO (STN 125769/203), March 14, 2024 Approval Letter - ABRYSVO (STN 125769/117), September 12, 2023 Summary Basis for Regulatory Action - ABRYSVO (STN 125768), Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO) (STN 125768)Refer to Section 1.1 of the Clinical Review Mem, Approval History, Letters, Reviews, and Related Documents - ABRYSVO (STN 125768), August 21, 2023 Approval Letter - ABRYSVO (STN 125769/26), August 21, 2023 Approval Letter - ABRYSVO (STN 125768), Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO)Refer to Section 1.1 of the Clinical Review Memo for informa, Approval History, Letters, Reviews, and Related Documents - ABRYSVO |
| FDA page updated | Feb 21, 2025 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 10–99 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: