8-K SHELL-Watson Generic Lidoderm Approval
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 24, 2012 (August 23, 2012)
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ENDO HEALTH SOLUTIONS INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware | 001-15989 | 13-4022871 |
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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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:
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o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 August 23, 2012, Endo Health Solutions Inc. announced that the U.S. Food and Drug Administration (FDA) denied Endo's Citizen Petition (CP) related to the approval requirements for generic versions of LIDODERM® (lidocaine patch 5%), a locally-acting topical medication for the relief of pain associated with post-herpetic neuralgia. The press release also discussed the FDA's approval of Watson Pharmaceuticals, Inc.'s generic version of LIDODERM.
A copy of the press release announcing the approval is attached hereto as Exhibit 99.1.
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Item 9.01. | Financial Statements and Exhibits. |
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(a) | Financial Statements of Business Acquired. |
Not applicable.
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(b) | Pro Forma Financial Information. |
Not applicable.
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(c) | Shell Company Transactions. |
Not applicable.
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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.
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ENDO HEALTH SOLUTIONS HOLDINGS INC. |
(Registrant) |
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By: | /s/ CAROLINE B. MANOGUE |
Name: | Caroline B. Manogue |
Title: | Executive Vice President, Chief Legal Officer & Secretary |
Dated: August 24, 2012
INDEX TO EXHIBITS
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Exhibit Number | | Description |
99.1 | | Press Release |