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|September 17, 2013 9:13 a.m.|
|FDA Approves Teva’s TREANDA® (bendamustine HCI) Injection, a New Liquid Formulation|
New Formulation Eliminates Need for Reconstitution
This new liquid formulation removes the step of reconstituting lyophilized powder with sterile water prior to adding the medicine to the dilutent and administering to a patient.
“By eliminating the need for reconstitution, a step is removed making dose preparation fast and convenient for healthcare professionals,” said
Teva was assigned a Priority Review designation for the supplemental New Drug Application (sNDA) for the new liquid formulation of TREANDA, which was submitted to the
“Teva is committed to continuously improving our medicines to deliver greater value to all stakeholders,” said
TREANDA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.
TREANDA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (
Important Safety Information
You are encouraged to report side effects of prescription drugs to the
About TREANDA (bendamustine HCI) Injection
TREANDA was approved by the
TREANDA has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of TREANDA remains unknown, bendamustine is active against both quiescent and dividing cells. Preclinical studies suggest that TREANDA may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway).
About Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia (CLL) is one of four main types of leukemia. CLL begins with a change to a single white blood cell, or lymphocyte, of the bone marrow. Over time, the CLL cells multiply, replacing normal lymphocytes in the marrow and lymph nodes. As the amount of lymphocytes increases in the blood and bone marrow, there is less room for healthy white and red blood cells as well as platelets, which may result in infection, anemia and bleeding.
About Indolent Non-Hodgkin lymphoma (
Non-Hodgkin lymphoma (
Indolent non-Hodgkin lymphomas (iNHL) are slow-growing lymphomas. The median survival of patients with indolent lymphoma is approximately 10 years. Indolent lymphomas are often responsive to therapy but usually relapse.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially COPAXONE® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.