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FDA approves Eagle Pharmaceuticals' RTD HCI solution in a 500ml admixture

Published 05/16/2018, 07:46 AM
© Reuters.  FDA approves Eagle Pharmaceuticals' RTD HCI solution in a 500ml admixture
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  • FDA has granted final approval for Eagle Pharmaceuticals' (NASDAQ:EGRX) ready-to-dilute (RTD) bendamustine hydrochloride ((HCl)) solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma.
  • Eagle’s bendamustine HCl injection does not require reconstitution and is administered as a 500ml admixture over 30 or 60 minutes.
  • Eagle has 13 U.S. patents covering different bendamustine formulations and methods.
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