FDA approved the original new drug application for OTEZLA on August 29, 2025, sponsored by AMGEN INC. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA210745
- Sponsor
- AMGEN INC
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- apremilast
Browse every approval whose brand starts with O, 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 |
|---|---|---|---|
| apremilast 30MG | TABLET | ORAL | Prescription |
| apremilast 20MG | TABLET | ORAL | Prescription |
| apremilast 75MG | TABLET, EXTENDED RELEASE | ORAL | Prescription |
| apremilast 10MG | TABLET | 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 2026-09-03). Every field on this page comes from that record.
An approval date is the start of the question, not the end
What a drug is worth to the company that owns it depends on what else is in the pipeline, how much cash is behind it and who else is running the same trial. FuzeBio reads a biotech end to end on demand — pipeline in plain English, trial design and endpoints, competitors, the cash position, and a valuation with its assumptions on the page. Moderna’s report is open in full, no account.
Open the Moderna reportA complete sample report — nothing held back, no sign-up.