VIJOICE
NDA 215039 · New Drug Application (NDA) Prescription
ALPELISIB
- Sponsor (Drugs@FDA)
- NOVARTIS 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 | VIJOICE ALPELISIB | TABLET;ORAL 50MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | VIJOICE ALPELISIB | TABLET;ORAL 125MG | Prescription | – | Reference listed drug | RXApproved |
| 003 | VIJOICE ALPELISIB | TABLET;ORAL 200MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Supplement 2 | Approved | standard | Efficacy | Letter for Supplement 2 (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 10 - New Indication Submitted as Distinct NDA - Not Consolidated | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
12 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 8476268Product 001 | Drug substance, Drug product | – | ||
| 8227462Product 001 | Drug substance, Drug product | – | ||
| 11433059Product 001 | Method of use | U-4359 | ||
| 12427141Product 001 | Method of use | U-4288 | ||
| 8476268Product 002 | Drug substance, Drug product | – | ||
| 8227462Product 002 | Drug substance, Drug product | – | ||
| 11433059Product 002 | Method of use | U-4359 | ||
| 12427141Product 002 | Method of use | U-4288 | ||
| 8476268Product 003 | Drug substance, Drug product | – | ||
| 8227462Product 003 | Drug substance, Drug product | – | ||
| 11433059Product 003 | Method of use | U-4359 | ||
| 12427141Product 003 | Method of use | U-4288 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| ODE-396 | 001 | |
| ODE-396 | 002 | |
| ODE-396 | 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.
VIJOICE
ALPELISIB · Novartis Pharmaceuticals Corporation · ORAL · Version 10 · effective
Indications and usage
1 INDICATIONS AND USAGE VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VIJOICE is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a 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 |
|---|---|---|---|---|---|
| 0078-1021 in openFDA (opens in a new tab) | VIJOICE alpelisib | Novartis Pharmaceuticals Corporation | TABLET ORAL | NDA | From |
| 0078-1028 in openFDA (opens in a new tab) | VIJOICE alpelisib | Novartis Pharmaceuticals Corporation | TABLET ORAL | NDA | From |
| 0078-1035 in openFDA (opens in a new tab) | VIJOICE alpelisib | Novartis Pharmaceuticals Corporation | KIT | 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 2026-10-25.
- 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.