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Treanda Approval History

FDA Approved: Yes (First approved March 20, 2008)
Brand name: Treanda
Generic name: bendamustine hydrochloride
Dosage form: Injection
Company: Cephalon, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma

Treanda (bendamustine) is a purine alkylator hybrid chemotherapy agent indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent non-Hodgkin's lymphoma.

Development History and FDA Approval Process for Treanda

DateArticle
Nov  3, 2008Approval Cephalon Receives FDA Approval for Treanda to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
Mar 20, 2008Approval Cephalon Receives FDA Approval for Treanda, a Novel Chemotherapyfor Chronic Lymphocytic Leukemia
Feb 19, 2008FDA Accepts Treanda New Drug Application for the Treatment ofRelapsed Indolent Non-Hodgkin's Lymphoma
Jan  2, 2008Cephalon Submits New Drug Application for Treanda for the Treatmentof Patients with Relapsed Indolent Non-Hodgkin's Lymphoma
Dec  3, 2007Treanda New Drug Application for the Treatment of ChronicLymphocytic Leukemia Granted Priority Review Status by FDA
Sep 21, 2007Cephalon Submits New Drug Application for Treanda for the Treatmentof Chronic Lymphocytic Leukemia
Jun 28, 2007Cephalon Announces Plans for New NDA Filing for Treanda

Further information

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