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EX-99.1 - EX-99.1 - Zyla Life Sciencesa17-15094_2ex99d1.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): June 20, 2017

 


 

Egalet Corporation

(Exact name of Registrant as specified in its charter)

 


 

Delaware

 

001-36295

 

46-3575334

(State or Other Jurisdiction
of Incorporation or Organization)

 

(Commission
File Number)

 

(I.R.S. Employer
Identification No.)

 

600 Lee Road, Suite 100

Wayne, Pennsylvania 19087

(610) 833-4200

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

Not Applicable

(Former name or former address, if changed since last report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 



 

Item 8.01 — Other Events

 

On June 20, 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 Company’s prior approval supplement for 10 mg and 15 mg dosage strengths of OXAYDO® (oxycodone HCI, USP) tablets for oral use only—CII, a copy of which is filed herewith as Exhibit 99.1.

 

Item 9.01 — Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit
Number

 

Description

 

 

 

99.1

 

Press Release, dated June 20, 2017

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: June 20, 2017

Egalet Corporation

 

 

 

 

By:

/s/ Stan Musial

 

 

Name: Stan Musial

 

 

Title: Chief Financial Officer

 

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