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Truxima FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 28, 2018.

FDA Approved: Yes (First approved November 28, 2018)
Brand name: Truxima
Generic name: rituximab-abbs
Dosage form: Injection
Company: Celltrion, Inc.
Treatment for: Non-Hodgkin's Lymphoma

Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.

  • The product label for Truxima contains a Boxed Warning to alert health care professionals and patients about the increased risk of fatal infusion reactions, severe skin and mouth reactions, Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy.
  • The FDA approval of Truxima is based on clinical data that demonstrates Truxima is biosimilar to Rituxan.
  • Truxima is administered as an intravenous infusion by a healthcare professional with appropriate medical support to manage severe infusion reactions that may occur.
  • Most common side effects reported in clinical trials were infusion reactions, fever, lymphopenia, chills, infection and asthenia.

Development timeline for Truxima

Nov 28, 2018Approval FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan

Further information

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