Egalet Corporation (NASDAQ:EGLT) Files An 8-K Other Events
Item 8.01 Other Events
On June20, 2017, Egalet Corporation (the Company) issued a press
release announcing that it has received a Complete Response
Letter from the U.S. Food and Drug Administration with respect to
the Companys prior approval supplement for 10 mg and 15 mg dosage
strengths of OXAYDO(oxycodone HCI, USP) tablets for oral use
onlyCII, a copy of which is filed herewith as Exhibit99.1.
Item 9.01 Financial Statements and Exhibits
(d)Exhibits
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Exhibit Number |
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Description |
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99.1 |
Press Release, dated June20, 2017 |
Egalet Corp ExhibitEX-99.1 2 a17-15094_2ex99d1.htm EX-99.1 Exhibit 99.1 Egalet Receives Complete Response Letter from U.S. Food and Drug Administration for Prior Approval Supplement for 10 mg and 15 mg Dosage Strengths of OXAYDO Wayne,…To view the full exhibit click here About Egalet Corporation (NASDAQ:EGLT)
Egalet Corporation is a specialty pharmaceutical company. The Company is engaged in developing, manufacturing and commercializing treatments for pain and other conditions. The Company’s products include OXAYDO and SPRIX Nasal Spray. The Company is developing two late-stage product candidates, ARYMO ER and Egalet-002 using Guardian Technology. The Company’s product SPRIX Nasal Spray, which contains ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) indicated in adult patients for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. The Company’s product OXAYDO is an approved immediate-release (IR) oxycodone product formulated to deter abuse through snorting. The Company’s product candidate, ARYMO ER is an abuse-deterrent (AD), extended-release (ER), oral morphine formulation. The Company’s product candidate, Egalet-002, is an abuse-deterrent, extended-release, oral oxycodone formulation.