- In a Phase 1 trial, Eagle Pharmaceuticals' (NASDAQ:EGRX +2.2%) 50 ml admixture of bendamustine hydrochloride delivered via 10-minute rapid infusion was equivalent to an admixture of 500 ml of Treanda (bendamustine HCL) delivered via 60-minute infusion. The study met its primary endpoint of bioequivalence.
- A more rapidly infused product would be beneficial to cancer patients.
- The FDA issued tentative approval for the low volume infusion in July 2014. It designated it an Orphan Drug for chronic lymphocytic leukemia and indolent B-cell non-Hodgkins lymphoma on July 2, 2014.
Eagle Pharma rapidly infused admix equivalent to Treanda
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