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FDA Accepts Endo Pharmaceuticals (ENDP)'s Complete Response Submission to New Drug Application for AVEED™ (Testosterone Undecanoate) Injection


9/5/2013 9:36:11 AM

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MALVERN, Pa., Sept. 5, 2013 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (Nasdaq: ENDP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo to the new drug application (NDA) for its long-acting testosterone undecanoate injection, AVEED, intended for men diagnosed with hypogonadism. In connection with the acceptance, the FDA assigned Endo's NDA a new Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2014.

"We are pleased that our complete response was accepted by the FDA," said Ivan Gergel, executive vice president of research and development and chief scientific officer of Endo. "We look forward to working with the FDA to complete the review process and make this treatment option available to appropriate male patients in the U.S. diagnosed with hypogonadism."

About Endo:

Endo Health Solutions Inc. (Endo) is a U.S.-based specialty healthcare company with four distinct business segments that are focused on branded and generic pharmaceuticals, devices and services, each providing quality products to our customers while improving the lives of patients. Through our operating companies AMS, Endo Pharmaceuticals, HealthTronics and Qualitest Endo is dedicated to finding solutions for the unmet needs of patients. 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 Pharmaceuticals Inc.



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