# AMPHASTAR PHARMS INC: efficacy supplement approved for REXTOVY

**Score:** 45/100

| Field | Value |
|---|---|
| Sponsor | AMPHASTAR PHARMS INC |
| Product | REXTOVY |
| Generic / ingredient | NALOXONE HYDROCHLORIDE |
| Approval | Drug efficacy supplement (new indication or use) |
| Application | NDA208969 supplement 2 |
| Decided | 2026-06-16 |
| Panel / class | SPRAY, METERED, NASAL |

## Why this score
- New indication or use: a relaunch.

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=208969). 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.