Treats advanced prostate cancer. NDA 211488, held by Accord. Leuprolide Mesylate.
As of Nov 14, 2026, NDA 211488 (Camcevi Kit), held by Accord, was first approved by FDA on May 25, 2021, with 4 approved supplements and 0 published complete response letters.
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 2021 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Camcevi KitEQ 42MG BASE · emulsion;subcutaneous | Leuprolide Mesylate | RxReference drug |
| Feb 11, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Sep 23, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Feb 11, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Mar 13, 2024 | Supplement 4Labeling · Standard review | Approved | |
| May 25, 2021 | Original applicationNew active ingredient · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
