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FDA Approves Liquid Formulation of Treanda (Bendamustine)

No need for powder (September 17)

The FDA has approved Treanda (bendamustine, Teva Pharmaceutical Industries) Injection, a new formulation of the currently approved Treanda (bendamustine) for Injection.

Treanda is indicated for use in patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen, and in patients with chronic lymphocytic leukemia (CLL).

The efficacy of Treanda in CLL relative to first-line therapies other than chlorambucil has not been established.

The new liquid formulation removes the step of reconstituting lyophilized powder with sterile water prior to adding the medicine to the dilutent and administering it to a patient.

Treanda (bendamustine) was approved by the FDA for the treatment of CLL in March 2008. The drug received its second approval in October 2008 for the treatment of patients with indolent B-cell NHL.

Source: Teva; September 17, 2013.

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