# OTSUKA PHARMACEUTICAL CO LTD: New drug application for SIMTRIYO

**Score:** 55/100

| Field | Value |
|---|---|
| Sponsor | OTSUKA PHARMACEUTICAL CO LTD |
| Product | SIMTRIYO |
| Generic / ingredient | CENTANAFADINE HYDROCHLORIDE |
| Approval | New drug application (NDA) |
| Application | NDA218145 |
| Decided | 2026-07-24 |
| Panel / class | CAPSULE, EXTENDED RELEASE |

## Why this score
- A new product launch.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218145). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.