Drugs@FDA document
PRALUENT Letter · BLA 125559 SUPPL-39
Drugs@FDA document · REGENERON PHARMACEUTICALS · Mar 11, 2024
Key facts
| Drug name | PRALUENT |
|---|---|
| Document type | Letter |
| Application | BLA125559 |
| Submission | SUPPL-39 |
| Company | REGENERON PHARMACEUTICALS |
| Document date | Mar 11, 2024 |
| FDA document | accessdata.fda.gov |
At a glance
- Efficacy-New Indication Document categories
- 10–99 Documents for this application
- 1–9 USP chapters cited in this application's documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA documents
Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date: