FDA approved the original new drug application for SUTENT on January 26, 2006, sponsored by CPPI CV. FDA has approved 4 efficacy supplements on the application since, the most recent on February 2, 2007.
- Application
- NDA021968
- Sponsor
- CPPI CV
- Original approval
- Review
- priority review
- Submission class
- Type 6 - New Indication (no longer used)
- Active ingredient
- sunitinib malate
Browse every approval whose brand starts with S, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| sunitinib malate EQ 50MG BASE | CAPSULE | ORAL | Prescription |
| sunitinib malate EQ 12.5MG BASE | CAPSULE | ORAL | Prescription |
| sunitinib malate EQ 25MG BASE | CAPSULE | ORAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
| Approved | Supplement | Review |
|---|---|---|
| S-4 | standard | |
| S-5 | priority | |
| S-3 | standard | |
| S-6 | priority |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 1 · Manufacturing (CMC) 1. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to CPPI CV
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