FDA approved the original new drug application for OMCAZIO on September 3, 2026. Today HANDA ONCOL holds the application (Drugs@FDA). FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA220613
- Sponsor
- HANDA ONCOL
- Original approval
- Review
- standard review
- Active ingredient
- cabozantinib laurylsulfate
Browse every approval whose brand starts with O, every approval FDA granted in 2026, or the complete response letters FDA has published — the applications it did not approve.
Or see what is dated ahead: open the catalyst desk. Upcoming trial readouts and FDA dates, with the document behind each date. Free, and no account.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| cabozantinib laurylsulfate EQ 34.5MG BASE | CAPSULE | ORAL | Prescription |
| cabozantinib laurylsulfate EQ 11.5MG BASE | CAPSULE | ORAL | Prescription |
| cabozantinib laurylsulfate EQ 23MG 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.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-26). Every field on this page comes from that record.
An approval date is the start of the question, not the end
What comes next for the company that owns this drug is often already dated. The catalyst desk carries dated trial readouts and regulatory events for the companies it tracks, not every event in biotech. Dates are read from ClinicalTrials.gov and company filings and checked once a day, and each row names the document its date came from.
Open the catalyst deskFree · No account