NDA 205580, held by Eagle Pharms. Bendamustine Hydrochloride.
As of Nov 14, 2026, NDA 205580 (Belrapzo), held by Eagle Pharms, was first approved by FDA on May 15, 2018, with 5 approved supplements and 0 published complete response letters.
BELRAPZO is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. 1.1 Chronic Lymphocytic Leukemia (CLL) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 15, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Belrapzo100MG/4ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | RxReference drug |
| Jan 11, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Jun 2, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Oct 14, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Oct 30, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Aug 31, 2018 | Supplement 2Labeling · Standard review | Approved | |
| May 15, 2018 | Original applicationNew formulation or manufacturer · 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
