ORLADEYO (BEROTRALSTAT HYDROCHLORIDE)
Summary
FDA approved ORLADEYO (BEROTRALSTAT HYDROCHLORIDE) by BIOCRYST. NDA (New Drug) approval (Type 3 - New Dosage Form) on 2025-12-11. PELLETS, ORAL.
Details
Source
Drug Approval
External ID
NDA219776-1
Action Date
2025-12-11
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ORLADEYO (generic: BEROTRALSTAT HYDROCHLORIDE), PELLETS, ORAL. Application: NDA219776
Company
Context & Analysis
BIOCRYST has 2 FDA actions in our database.
Frequently Asked Questions
How often does BIOCRYST have FDA actions?
BIOCRYST has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA219776-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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