BLA 761140, held by Amgen Inc. Rituximab-Arrx.
As of Nov 13, 2026, BLA 761140 (Riabni), held by Amgen Inc, was first approved by FDA on Dec 17, 2020, with 3 approved supplements and 0 published complete response letters.
RIABNI is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riabni100MG/10ML(10MG/ML) · injectable;injection | Rituximab-Arrx | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2026 | Supplement 5Bioequivalence | Approved | |
| Jun 9, 2025 | Supplement 4Bioequivalence | Approved | |
| Jun 3, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2020 | Original application | 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
