FDA approved the original new drug application for REXULTI on July 10, 2015, sponsored by OTSUKA. FDA has approved 5 efficacy supplements on the application since, the most recent on May 9, 2025.
- Application
- NDA205422
- Sponsor
- OTSUKA
- Original approval
- Review
- standard review
- Submission class
- Efficacy
- Active ingredient
- brexpiprazole
Browse every approval whose brand starts with R, 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 |
|---|---|---|---|
| brexpiprazole 3MG | TABLET | ORAL | Prescription |
| brexpiprazole 1MG | TABLET | ORAL | Prescription |
| brexpiprazole 0.25MG | TABLET | ORAL | Prescription |
| brexpiprazole 4MG | TABLET | ORAL | Prescription |
| brexpiprazole 2MG | TABLET | ORAL | Prescription |
| brexpiprazole 0.5MG | 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.
| Approved | Supplement | Review |
|---|---|---|
| S-1 | standard | |
| S-7 | priority | |
| S-9 | priority | |
| S-11 | priority | |
| S-14 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 6. 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.
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.