# GENENTECH: efficacy supplement approved for GAZYVA

**Score:** 45/100

| Field | Value |
|---|---|
| Sponsor | GENENTECH |
| Product | GAZYVA |
| Generic / ingredient | OBINUTUZUMAB |
| Approval | Drug efficacy supplement (new indication or use) |
| Application | BLA125486 supplement 43 |
| Decided | 2026-09-25 |
| Panel / class | INJECTABLE, INJECTION |

## 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=125486). Last refreshed: 2026-11-05T08:47:15.055Z.
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.