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Product Indentification


Name:   Bendamustine HCl
Synonyms:   Treanda™,Bendamustinum;Bendamustina;DD6304600;SDX-105;4-(5-(bis(2- chloroethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid; 2-Benzimidazolebutyric acid, 5-(bis(2-chloroethyl)amino)-1-methyl-;5-(Bis(2-chloroethyl)amino)-1-methyl-2-benzimidazolebutyric acid;1H-Benzimidazole-2-butanoic acid, 5-(bis(2-chloroethyl)amino)-1-methyl-.

4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid

CAS Registry Number:   3543-75-7 (HCl salt); 16506-27-2 (Free base))
Molecular Formula:   C16H22Cl3N3O2
Molecular Weight:    394.72
Molecular Structure:    


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                    Storage: 4 deg.                 



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Bendamustine was first synthesized in 1963 by Ozegowski and Krebs in East Germany (the former German Democratic Republic). It is a white, water soluble microcrystalline powder with amphoteric properties. Until 1990 it was available only in East Germany. East German investigators found that it was useful for treating chronic lymphocytic leukemia, Hodgkin’s disease, non-Hodgkin’s lymphoma, multiple myeloma and lung cancer.

Bendamustine received its first marketing approval in Germany, which is marketed under the tradename Ribomustin, by Astellas Pharma GmbH's licensee, Mundipharma International Corporation Limited, which it is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.

In March 2008, Cephalon received approval from the United States Food and Drug Administration to market bendamustine in the US, where it is sold under the tradename Treanda, for treatment of CLL.  In October 2008, the FDA granted further approval to market Treanda for the treatment of indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.









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