BENDEKA (bendamustine hydrochloride)
On February 8th, 2016
FDA approval alert: new drug approved for treatment of CLL and non-hodgkin lymphoma
BENDEKA (bendamustine hydrochloride) injection has been approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
The drug, which is a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine, was granted Orphan Drug status for both diseases and has shown considerable success in patients whose cancer has progressed.
BENDEKA was developed by Eagle Pharmaceuticals, Inc. and will be promoted and distributed by Teva Pharmaceutical Industries Ltd. [Emphasis mine. MJR ]
It is expected to be commercially available in February of 2016.
BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.
For bendamustine hydrochloride injection full prescribing information, please visit: http://www.bendeka.com/PrescribingInformation.PDF
FDA approval alert: new drug approved for treatment of CLL and non-hodgkin lymphoma
BENDEKA (bendamustine hydrochloride) injection has been approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.
The drug, which is a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine, was granted Orphan Drug status for both diseases and has shown considerable success in patients whose cancer has progressed.
BENDEKA was developed by Eagle Pharmaceuticals, Inc. and will be promoted and distributed by Teva Pharmaceutical Industries Ltd. [Emphasis mine. MJR ]
It is expected to be commercially available in February of 2016.
BENDEKA was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.
For bendamustine hydrochloride injection full prescribing information, please visit: http://www.bendeka.com/PrescribingInformation.PDF
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