Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219776
Company: BIOCRYST
Company: BIOCRYST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 72MG BASE/PACKET | PELLETS;ORAL | Prescription | None | Yes | No |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 96MG BASE/PACKET | PELLETS;ORAL | Prescription | None | Yes | No |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 108MG BASE/PACKET | PELLETS;ORAL | Prescription | None | Yes | No |
| ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | EQ 132MG BASE/PACKET | PELLETS;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/11/2025 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219776Orig1s000ltr.pdf |