← FDA Drug Approvals (Drugs@FDA)
ORLADEYO
NDA · New Drug Application · Sponsor: BIOCRYST · Approved 2025-12-11
Drug application
- FDA Application #
NDA219776- Application type
- New Drug Application
- Brand name
- ORLADEYO
- Generic name
- BEROTRALSTAT HYDROCHLORIDE
- Active ingredients
- BEROTRALSTAT DIHYDROCHLORIDE
- Dosage form
- PELLETS
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BIOCRYST
- Manufacturer
- BioCryst Pharmaceuticals, Inc.
- First approval
- 2025-12-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown