Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Other EventsItem 8.01 Other Events.
On October27, 2017, Eagle Pharmaceuticals,Inc., or the Company, issued a press release announcing that the United States Food and Drug Administration has granted tentative approval for the Company’s PEMFEXY™, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.
A copy 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 October27, 2017
|
EAGLE PHARMACEUTICALS, INC. ExhibitEX-99.1 2 a17-24604_1ex99d1.htm EX-99.1 Exhibit 99.1 For Immediate Release Eagle Pharmaceuticals Receives Tentative FDA Approval for PEMFEXY (Pemetrexed Injection) Ready-to-Dilute 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.