approval · primary record
BEROTRALSTAT DIHYDROCHLORIDE
2 approval events · latest 2026-10-16
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-10-16 |
| Approval events | 2 |
| Brand | ORLADEYO |
| Sponsor | BIOCRYST |
| Route | ORAL |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-10-16 | FDA | NDA | ORLADEYO | BIOCRYST | ORAL |
| 2025-12-11 | FDA | NDA | ORLADEYO | BIOCRYST | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:32:00.622Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:berotralstat-dihydrochloride
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Berotralstat Dihydrochloride · compound