ISEMBYLD
BLA 761463 · Biologics License Application (BLA) Prescription
APITEGROMAB-MSTN
- Sponsor (Drugs@FDA)
- SCHOLAR ROCK INC Company: Scholar Rock Holding Corp (SRRK)
- 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 | ISEMBYLD APITEGROMAB-MSTN | INJECTABLE;INJECTION 150MG/3ML (50MG/ML) | Prescription | – | No | Not listed |
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
No Orange Book patents are listed for this application.
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Purple Book licensure
| Product | Licence | Strength and presentation | Licensed on | First licensure | Reference product | Exclusivity |
|---|---|---|---|---|---|---|
| Isembyld 001apitegromab-mstn · Scholar Rock, Inc. | 351(a) Licensed · Rx | 150MG/3ML (50MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | – |
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 84717-150 in openFDA (opens in a new tab) | ISEMBYLD apitegromab-mstn | Scholar Rock, Inc. | INJECTION INTRAVENOUS | BLA | 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.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
- 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.