Treats metastatic colorectal cancer. NDA 211226, held by Acrotech Biopharma. Levoleucovorin.
As of Nov 15, 2026, NDA 211226 (Khapzory), held by Acrotech Biopharma, was first approved by FDA on Oct 19, 2018, with 1 approved supplement and 0 published complete response letters.
KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B 12 because of the risk of progression of neurologic manifestations despite hematologic remission.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2018 | Original applicationNew active ingredient · Standard review | Approved |
| Khapzory175MG/VIAL · powder;intravenous | Levoleucovorin | RxReference drug |
| Khapzory300MG/VIAL · powder;intravenous | Levoleucovorin | DiscontinuedReference drug |
| Mar 3, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Oct 19, 2018 | 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
