# PIXCLARA (Floretyrosine F18) by Telix Pharmaceuticals (US) Inc.: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | PIXCLARA |
| Generic name | Floretyrosine F18 |
| NDC | 74725-338 |
| Labeler | Telix Pharmaceuticals (US) Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA |
| Application number | NDA218592 |
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Active ingredients | FLORETYROSINE F-18 300 mCi/mL |
| Marketing start | 2026-09-11 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=74725-338). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.