8-K SHELL-FDA Lawsuit
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
Date of Report (Date of Earliest Event Reported): December 3, 2012 (November 30, 2012)

_______________________________
ENDO HEALTH SOLUTIONS INC.
(Exact Name of Registrant as Specified in Its Charter)  
_______________________________
Delaware
001-15989
13-4022871
(State or other jurisdiction
of incorporation)
(Commission File Number)
(I.R.S. Employer
Identification No.)
100 Endo Boulevard, Chadds Ford, PA
19317
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code (610) 558-9800
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 (17 CFR 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))
 
 



Item 8.01. Other Events.
On November 30, 2012, Endo Health Solutions Inc. announced that its subsidiary, Endo Pharmaceuticals Inc., had filed suit against the U.S. Food and Drug Administration (FDA) seeking a formal determination whether the original formulation of OPANA® ER (oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications (ANDAs) for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons.

A copy of the press release announcing the lawsuit is attached hereto as Exhibit 99.1.
Item 9.01.
Financial Statements and Exhibits.
(a)
Financial Statements of Business Acquired.
Not applicable.
(b)
Pro Forma Financial Information.
Not applicable.
(c)
Shell Company Transactions.
Not applicable.
(d)
Exhibits.
Exhibit Number
 
Description 
99.1
 
Press Release




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, hereunto duly authorized.
 
 
 
ENDO HEALTH SOLUTIONS HOLDINGS INC.
(Registrant)
 
 
By:
/s/ CAROLINE B. MANOGUE
Name:
Caroline B. Manogue
Title:
Executive Vice President, Chief Legal Officer & Secretary
Dated: December 3, 2012



INDEX TO EXHIBITS
 
Exhibit Number
 
Description 
99.1
 
Press Release