Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Other EventsItem 8.01 Other Events.
On June11, 2018, Eagle Pharmaceuticals,Inc., or the Company, issued a press release announcing that the U.S. District Court for the District of Columbia has issued a decision requiring the U.S. Food and Drug Administration to grant seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.
A copy of the full text of the press release referenced above is filed as Exhibit99.1 to this Current Report on Form8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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ExhibitNo.
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Description
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99.1
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Press Release dated June11, 2018
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EAGLE PHARMACEUTICALS, INC. ExhibitEX-99.1 2 a18-15146_1ex99d1.htm EX-99.1 Exhibit 99.1 For Immediate Release Court Issues Decision in Favor of Eagle Pharmaceuticals Granting Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection) Generic TREANDA entry now not expected until December 2022 Further Protects Longevity of BENDEKA franchise WOODCLIFF LAKE,…To view the full exhibit click here
About Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX)
Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company focuses on developing and commercializing injectable products in the critical care and oncology areas. The Company’s product portfolio includes EP-1101 (argatroban); Ryanodex (dantrolene sodium); docetaxel injection, non-alcohol formulation (Non-Alcohol Docetaxel Injection); diclofenac-misoprostol; EP-3101 (Bendamustine Hydrochloride Injection, ready-to-dilute (RTD) concentrate solution), and EP-3102 (rapidly infused bendamustine RTD) (EP-3102 Bendeka). It has over four product candidates in advanced stages of development, and/or under review for approval by the United States Food and Drug Administration (FDA), which include EP-6101 Kangio ready-to-use (RTU) bivalirudin; EP-4104 (dantrolene sodium) (EP-4104) for exertional heat stroke (EHS), and EP-5101 (pemetrexed) (EP-5101). Its near-term product candidate, Kangio is a liquid intravenous form of Angiomax for percutaneous transluminal angioplasty.