Rituxan Approval History
Reviewed by J.Stewart BPharm Last updated on Sep 30, 2019.
FDA Approved: Yes (First approved November 26, 1997)
Brand name: Rituxan
Generic name: rituximab
Dosage form: Injection for Intravenous Use
Company: Genentech, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Non-Hodgkin's Lymphoma, Granulomatosis with Polyangiitis, Microscopic polyangiitis, Pemphigus
Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.
Rituxan is indicated for the treatment of:
- Non-Hodgkin’s Lymphoma (NHL) in adult patients with:
- relapsed or refractory, low grade or follicular, CD20-positive Bcell 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.
- previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
- Chronic Lymphocytic Leukemia (CLL) in adult patients with:
- previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
- Rheumatoid Arthritis (RA) in adult patients with:
- moderately-to severely-active RA, in combination with methotrexate, and an inadequate response to one or more TNF antagonist therapies.
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and
Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of
age and older
- in combination with glucocorticoids.
- Pemphigus Vulgaris (PV) in adult patients.
Development History and FDA Approval Process for Rituxan
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