# VANDA PHARMS INC: manufacturing (CMC) supplement approved for HETLIOZ

**Score:** 40/100

| Field | Value |
|---|---|
| Sponsor | VANDA PHARMS INC |
| Product | HETLIOZ |
| Generic / ingredient | TASIMELTEON |
| Approval | Drug manufacturing (CMC) supplement |
| Application | NDA205677 supplement 13 |
| Decided | 2026-07-27 |
| Panel / class | CAPSULE, ORAL |

## Why this score
- Manufacturing change: sites, suppliers or process.

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=205677). 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.