Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - ACURA PHARMACEUTICALS, INC | v324156_ex99-1.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D. C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act Of 1934
September 20, 2012
Date of Report (Date of earliest event reported)
___________________________________________________________
ACURA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
___________________________________________________________
| State of New York | 1-10113 | 11-0853640 | ||
| (State of Other Jurisdiction | (Commission File Number) | (I.R.S. Employer | ||
| of Incorporation) | Identification Number) |
616 N. North Court, Suite 120
Palatine, Illinois 60067
(Address of principal executive offices) (Zip Code)
(847) 705-7709
(Registrant’s telephone number, including area code)
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 (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17CFR240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c)) |
| Item 8.01 | Other Events |
On September 20, 2012, we issued a press release announcing that we had received notice from a generic sponsor of a Paragraph IV Certification advising us of the filing of an abbreviated new drug application with the U.S. Food and Drug Administration (“FDA”) listing Pfizer Inc’s OXECTA® (oxycodone hydrochloride) Tablets CII as the reference listed drug and asserting that the generic sponsor believes that our patents listed in the FDA’s Orange Book for OXECTA® are either invalid, unenforceable or not infringed thereby. A copy of our press release dated September 20, 2012, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
| Exhibit Number | Description | |
| 99.1 | Press Release dated September 20, 2012 announcing filing of Paragraph IV Certification. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ACURA PHARMACEUTICALS, INC. |
| By: | /s/ Peter A. Clemens | |
| Peter A. Clemens | ||
| Senior Vice President & Chief Financial Officer |
Date: September 20, 2012
Exhibit Index
| Exhibit Number | Description | |
| 99.1 | Press Release dated September 20, 2012 announcing filing of Paragraph IV Certification. |