Prevents Respiratory Syncytial Virus (RSV) lower respiratory tract disease. Sold as Beyfortus. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Nirsevimab-Alip (sold as Beyfortus), first approved Jul 17, 2023, with 2 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 17, 2023 | BeyfortusBLA 761328 ยท New molecular entity | Astrazeneca AB | 4 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
Astrazeneca AB