FDA approved the original new drug application for ORLADEYO on December 11, 2025, sponsored by BIOCRYST. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA219776
- Sponsor
- BIOCRYST
- Original approval
- Review
- priority review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- berotralstat dihydrochloride
Browse every approval whose brand starts with O, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| berotralstat dihydrochloride EQ 132MG BASE/PACKET | PELLETS | ORAL | Prescription |
| berotralstat dihydrochloride EQ 96MG BASE/PACKET | PELLETS | ORAL | Prescription |
| berotralstat dihydrochloride EQ 108MG BASE/PACKET | PELLETS | ORAL | Prescription |
| berotralstat dihydrochloride EQ 72MG BASE/PACKET | PELLETS | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BIOCRYST
An approval date is the start of the question, not the end
What a drug is worth to the company that owns it depends on what else is in the pipeline, how much cash is behind it and who else is running the same trial. FuzeBio reads a biotech end to end on demand — pipeline in plain English, trial design and endpoints, competitors, the cash position, and a valuation with its assumptions on the page. Moderna’s report is open in full, no account.
Open the Moderna reportA complete sample report — nothing held back, no sign-up.