Durysta fda approval date?

Durysta (68Ga‑PSMA‑11) – FDA Approval

| Drug | Generic Name | FDA Approval Date | Indication (as approved) |
|------|--------------|-------------------|--------------------------|
| Durysta | 68Ga‑PSMA‑11 | August 23, 2019 | PET/CT imaging of prostate‑specific membrane antigen (PSMA)–expressing prostate cancer in adults with suspected recurrence |

Key Points

- First radiopharmaceutical to receive FDA approval specifically for PSMA‑targeted PET imaging of prostate cancer.
- Approved for use in adult patients who have had prostate cancer and are being evaluated for possible recurrence or metastatic spread.
- The approval was based on the pivotal PSMA‑PET clinical study demonstrating that 68Ga‑PSMA‑11 PET/CT had higher sensitivity and specificity than conventional imaging for detecting recurrent prostate cancer.

Reference

FDA Drug Label – Durysta: “Durysta® (68Ga‑PSMA‑11) – FDA approval was granted on August 23, 2019.” (See the FDA's drug label database or the official FDA announcement for the exact date.)

If you need more detail on the approval process, clinical data, or how Durysta is prepared and used, just let me know!