Licensed vaccine
AREXVY
FDA-licensed vaccine · GlaxoSmithKline Biologicals SA · STN 125775
Key facts
| Trade name | AREXVY |
|---|---|
| Proper name | Respiratory Syncytial Virus Vaccine, Adjuvanted |
| Manufacturer | GlaxoSmithKline Biologicals SA |
| Submission tracking number (STN) | 125775 |
| Recent FDA documents | January 6, 2025 Approval Letter - AREXVY, August 21, 2024 Approval Letter - AREXVY, June 7, 2024 Approval Letter - AREXVY, Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine, Adjuvanted (AREXVY)Refer to Section 1.1 of the Clinical Review Memo, Approval History, Letters, Reviews, and Related Documents - AREXVY, May 3, 2023 Summary Basis for Regulatory Action - AREXVY, May 23, 2023 Approval Letter - AREXVY, Package Insert - AREXVY, FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and ArexvyJanuary 7, 2025 |
| FDA page updated | Jan 8, 2025 |
| FDA product page | fda.gov |
At a glance
- 1–9 FDA approval letters
- 1–9 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: