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Eagle Pharmaceuticals receives orphan drug designation for bendamustine hydrochloride from United States Food and Drug Administration.

M2 PHARMA-July 10, 2014-Eagle Pharmaceuticals receives orphan drug designation for bendamustine hydrochloride from United States Food and Drug Administration

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Eagle Pharmaceuticals, a specialty pharmaceutical company, has received orphan drug designation for its bendamustine hydrochloride from the United States Food and Drug Administration (FDA), it was reported yesterday.

The product is to be used for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma. It is a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride (saline) or a saline/dextrose mixture.

The firm is eligible to receive tax incentives and Prescription Drug User Fee Act free savings based on the orphan drug designation, and it expects that it is likely to receive seven years of marketing exclusivity. Eagle Pharmaceuticals president and chief executive officer, Scott Tarriff, stated that the company is happy to have received orphan drug designation from the FDA as it advances the development pathway of bendamustine hydrochloride.

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Publication:M2 Pharma
Date:Jul 10, 2014
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