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Endo Health Solutions Inc. (Formerly Known as Endo Pharmaceuticals Holdings Inc.) (ENDP) Completes Transition of OPANA® ER Franchise to New Formulation Designed to be Crush Resistant


6/14/2012 11:20:16 AM

CHADDS FORD, Pa., June 14, 2012 /PRNewswire/ -- Endo Health Solutions (Nasdaq: ENDP), today announced the completion of the company's transition of its OPANA ER franchise to the new formulation designed to be crush resistant. In connection with the completion of this transition, the U.S. Food and Drug Administration (FDA) has moved the old formulation of OPANA ER to the Orange Book Discontinued List.

"While the original formulation of OPANA ER was deemed by FDA to be safe and effective when taken according to the prescribing information, the original formulation was subject to both intentional and inadvertent abuse and misuse," said Dr. Ivan Gergel, chief scientific officer of Endo. "Patient safety is our top concern and addressing appropriate use of opioids is a responsibility that we take very seriously. We firmly believe that the new formulation of OPANA ER, coupled with our long-term commitment to awareness and education around appropriate use of opioids will benefit patients, physicians and payers."

As a result of the FDA placing OPANA ER (NDA 21-610) in the Orange Book Discontinued List, all strengths of the original formulation of OPANA ER are now on the Discontinued List. The OPANA ER (NDA 21-610) 7.5 mg and 15 mg dosage strengths were moved to the Discontinued List previously. The new formulation of OPANA ER designed to be crush resistant (under NDA 201655) remains on the approved prescription drug product list as it is the only currently available formulation.

About Endo

Endo Health Solutions Inc. (Endo) is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Endo Health Solutions Inc.


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