YUVIWEL
NDA 219164 · New Drug Application (NDA) Prescription
NAVEPEGRITIDE
- Sponsor (Drugs@FDA)
- ASCENDIS Company: Ascendis Pharma A/S (ASND)
- 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 | YUVIWEL NAVEPEGRITIDE | POWDER;SUBCUTANEOUS 1.3MG/VIAL | Prescription | – | Reference listed drug, Reference standard | RXApproved |
| 002 | YUVIWEL NAVEPEGRITIDE | POWDER;SUBCUTANEOUS 2.8MG/VIAL | Prescription | – | Reference listed drug, Reference standard | RXApproved |
| 003 | YUVIWEL NAVEPEGRITIDE | POWDER;SUBCUTANEOUS 5.5MG/VIAL | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | priority | 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
36 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 8906847Product 001 | Drug substance, Drug product | U-4425 | ||
| 10835578Product 001 | Drug substance, Drug product | U-4425 | ||
| 11154593Product 001 | Drug substance, Drug product | U-4425 | ||
| 11224661Product 001 | Drug substance, Drug product | – | ||
| 11311604Product 001 | Drug substance, Drug product | U-4425 | ||
| 11389510Product 001 | Drug substance, Drug product | – | ||
| 11389511Product 001 | Drug product | U-4425 | ||
| 11413351Product 001 | Drug substance, Drug product | – | ||
| 12083182Product 001 | Method of use | U-4425 | ||
| 12156917Product 001 | Method of use | U-4425 | ||
| 12239689Product 001 | Method of use | U-4425 | ||
| 12377133Product 001 | Drug product | U-4425 | ||
| 8906847Product 002 | Drug substance, Drug product | U-4425 | ||
| 10835578Product 002 | Drug substance, Drug product | U-4425 | ||
| 11154593Product 002 | Drug substance, Drug product | U-4425 | ||
| 11224661Product 002 | Drug substance, Drug product | – | ||
| 11311604Product 002 | Drug substance, Drug product | U-4425 | ||
| 11389510Product 002 | Drug substance, Drug product | – | ||
| 11389511Product 002 | Drug product | U-4425 | ||
| 11413351Product 002 | Drug substance, Drug product | – | ||
| 12083182Product 002 | Method of use | U-4425 | ||
| 12156917Product 002 | Method of use | U-4425 | ||
| 12239689Product 002 | Method of use | U-4425 | ||
| 12377133Product 002 | Drug product | U-4425 | ||
| 8906847Product 003 | Drug substance, Drug product | U-4425 | ||
| 10835578Product 003 | Drug substance, Drug product | U-4425 | ||
| 11154593Product 003 | Drug substance, Drug product | U-4425 | ||
| 11224661Product 003 | Drug substance, Drug product | – | ||
| 11311604Product 003 | Drug substance, Drug product | U-4425 | ||
| 11389510Product 003 | Drug substance, Drug product | – | ||
| 11389511Product 003 | Drug product | U-4425 | ||
| 11413351Product 003 | Drug substance, Drug product | – | ||
| 12083182Product 003 | Method of use | U-4425 | ||
| 12156917Product 003 | Method of use | U-4425 | ||
| 12239689Product 003 | Method of use | U-4425 | ||
| 12377133Product 003 | Drug product | U-4425 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| ODE-516 | 001 | |
| NCE | 002 | |
| ODE-516 | 002 | |
| NCE | 003 | |
| ODE-516 | 003 |
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.
Yuviwel
NAVEPEGRITIDE · Ascendis Pharma Endocrinology, Inc. · Version 4 · effective
Indications and usage
1 INDICATIONS AND USAGE YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velocity . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )
NDC products
3 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 73362-201 in openFDA (opens in a new tab) | Yuviwel Navepegritide | Ascendis Pharma Endocrinology, Inc. | KIT | NDA | From |
| 73362-202 in openFDA (opens in a new tab) | Yuviwel Navepegritide | Ascendis Pharma Endocrinology, Inc. | KIT | NDA | From |
| 73362-203 in openFDA (opens in a new tab) | Yuviwel Navepegritide | Ascendis Pharma Endocrinology, Inc. | KIT | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
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.