REDEMPLO
NDA 219947 · New Drug Application (NDA) Prescription
PLOZASIRAN SODIUM
- Sponsor (Drugs@FDA)
- ARROWHEAD Company: ARROWHEAD PHARMACEUTICALS, INC. (ARWR)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | REDEMPLO PLOZASIRAN SODIUM | SOLUTION;SUBCUTANEOUS EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | standard | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
5 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10294474Product 001 | Drug substance, Drug product | U-4360 | ||
| 11174481Product 001 | Drug substance, Drug product | – | ||
| 11214801Product 001 | Drug substance, Drug product | U-4360 | ||
| 12365899Product 001 | Drug substance, Drug product | U-4360 | ||
| 10597657Product 001 | Drug substance, Drug product | U-4360 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| ODE-541 | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
REDEMPLO
PLOZASIRAN · Arrowhead Pharmaceuticals, Inc. · SUBCUTANEOUS · Version 4 · effective
Indications and usage
1 INDICATIONS AND USAGE REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is an apolipoprotein C-III ( apoC-III )-directed small interfering ribonucleic acid (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 84141-025 in openFDA (opens in a new tab) | REDEMPLO plozasiran | Arrowhead Pharmaceuticals, Inc. | INJECTION, SOLUTION SUBCUTANEOUS | NDA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-11-03.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-11-03.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-11-03.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-11-03.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.