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News Breaks
July 8, 2014
07:03 EDTEGRX, TEVAEagle Pharmaceuticals receives orphan drug designation for bendamustine HCl
Eagle Pharmaceuticals (EGRX) announced that the FDA has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings, and believes it may receive seven years of marketing exclusivity. The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries (TEVA), is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
News For EGRX;TEVA From The Last 14 Days
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September 29, 2014
07:19 EDTTEVAUBS to hold a field trip
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05:26 EDTTEVAProtalix appoints Moshe Manor as CEO
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September 17, 2014
11:01 EDTTEVAActavis drops after NY AG seeks to block Alzheimer drug switch
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08:05 EDTEGRX, TEVAEagle Pharm says Teva requests motion to dismiss Bendamustine lawsuit
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