Egalet Corporation (NASDAQ:EGLT) Files An 8-K Other Events

ME Staff 8-k
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Egalet Corporation (NASDAQ:EGLT) Files An 8-K Other Events
Item 8.01 — Other Events.

On December15, 2017, Egalet Corporation issued a press release announcing that the U.S. Food and Drug Administration has issued tentative approval for its Supplemental New Drug Application for ARYMO ER that it submitted in February2017. A copy of the press release is attached as Exhibit99.1 hereto and is incorporated into this Item 8.01 by reference.

Item 9.01 – Financial Statements and Exhibits.

(d) Exhibits.

ExhibitNumber

Description

99.1

Press Release, dated December15, 2017.


Egalet Corp Exhibit
EX-99.1 2 a17-28541_1ex99d1.htm EX-99.1 Exhibit 99.1     Egalet Receives FDA Tentative Approval for Expanded Label for ARYMO® ER (morphine sulfate) C-II,…
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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.