Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Other Events

ME Staff 8-k
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Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Other Events
Item 8.01 Other Events.

On July9, 2018, Eagle Pharmaceuticals,Inc., or the Company, issued a press release announcing that (i)consistent with the order issued by the U.S. District Court for the District of Columbia, or the Court, the U.S. Food and Drug Administration, or the FDA, has granted 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, and (ii)the FDA filed a motion with the Court asking the Court to clarify that the order was not intended to affect applications referencing TREANDA®.

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

ExhibitNo.

Description

99.1

Press Release dated July9, 2018


EAGLE PHARMACEUTICALS, INC. Exhibit
EX-99.1 2 a18-17001_1ex99d1.htm EX-99.1 Exhibit 99.1     For Immediate Release   FDA Grants Eagle Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection)   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.