ADAKVEO
BLA 761128 · Biologics License Application (BLA) Prescription
CRIZANLIZUMAB-TMCA
- Sponsor (Drugs@FDA)
- NOVARTIS PHARMS CORP Company: NOVARTIS AG (NVS, NVSEF)
- 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 | ADAKVEO CRIZANLIZUMAB-TMCA | INJECTABLE; INJECTION 100MG/10ML | Prescription | – | No | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 6 | Approved | standard | Efficacy | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Supplement 1 | Approved | standard | Labeling | Letter for Supplement 1 (opens in a new tab)Label for Supplement 1 (opens in a new tab) | |
| 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 |
|---|---|---|---|---|---|---|
| Adakveo 001crizanlizumab-tmca · Novartis Pharmaceuticals Corporation | 351(a) Licensed · Rx | 100MG/10ML (10MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | Orphan exclusivity expires |
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.
ADAKVEO
CRIZANLIZUMAB · Novartis Pharmaceuticals Corporation · INTRAVENOUS · Version 8 · effective
Indications and usage
1 INDICATIONS AND USAGE ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0078-0883 in openFDA (opens in a new tab) | ADAKVEO crizanlizumab | Novartis Pharmaceuticals Corporation | INJECTION INTRAVENOUS | BLA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
- 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.