Eagle Pharmaceuticals Inc. (Nasdaq:EGRX) (“Eagle” or “the Company”)
announced today that the United States Food and Drug Administration
(“FDA”) has granted orphan drug designation to bendamustine
hydrochloride (“HCl”), 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, for the treatment of chronic lymphocytic leukemia (“CLL”) and
indolent B-cell non-Hodgkin’s lymphoma (“NHL”).
Pursuant to the orphan drug designation, Eagle is eligible to receive
tax incentives and Prescription Drug User Fee Act (“PDUFA”) fee savings,
and believes it may receive seven years of marketing exclusivity.
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