The US Food and Drug Administration (:FDA) recently issued a complete response letter (CRL) for Endo Health Solutions (ENDP) new drug application on Aveed. The company is looking to get Aveed (a long-acting testosterone undecanoate injection) approved as a treatment for male hypogonadism.

The FDA declined to approve the new drug application for Aveed in the present form, as it is apprehensive about the risks and complications which may emanate after the injection of the drug. While issuing the CRL, the US regulatory body asked Endo to develop a medication guide. Specifically, the FDA asked Endo to ensure that the Risk Evaluation and Mitigation Strategy includes the guide in addition to Elements to Assure Safe Use to address the safety issue mentioned above.

However, the US regulatory body did not ask the company to conduct additional studies on Aveed. The requirement of additional trials would have pushed up its research and development costs. Endo intends to respond to the CRL by the end of the third quarter of 2013.

We note that the Aveed setback is not the first one for Endo this year. Last month, Endo suffered a blow with the FDA turning down its request to prevent the entry of generic versions of its painkiller, Opana ER. The decision by the FDA implies that the generic formulations of the original version of Opana ER will continue to be available in the market.

Endo expects the FDA decision to impact its 2013 guidance adversely. The company expects the adverse FDA ruling to reduce 2013 total net sales of Opana ER by up to $120 million. Moreover, Endos 2013 adjusted earnings per share outlook is expected to be hurt by approximately 55 cents following the FDA verdict.

While announcing its first-quarter 2013 results, Endo stated that it expects adjusted earnings per share for 2013 in the range of $4.40$4.70 per share and revenues of $2.80$2.95 billion. The Zacks Consensus Estimate for 2013 pegs earnings at $4.31 per share on revenues of $2.8 billion. Endo intends to throw more light on its 2013 guidance in the coming months.

Moreover, another painkiller at Endo, Lidoderm is expected to face generic competition later in the year from Actavis, Inc. (ACT). This will hamper sales of the drug significantly.

Endo currently carries a Zacks Rank #3 (Hold). Jazz Pharmaceuticals (JAZZ) and Santarus, Inc. (SNTS) appear to be more attractive with a Zacks Rank #1 (Strong Buy) each.

Read the Full Research Report on ACT

Read the Full Research Report on SNTS

More here:

CRL for Endo Health's Aveed

MALVERN, Pa., May 30, 2013 /PRNewswire/ --Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (ENDP) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism.

The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions.

"We are encouraged by the feedback received from the FDA in the complete response and appreciate the clarity around the path forward for AVEED," said Ivan Gergel, executive vice president of research and development and chief scientific officer of Endo Health Solutions. "We plan to submit a complete response by the end of the third quarter of 2013. We look forward to making 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 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 value for patients, providers and payers alike. Learn more at http://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.

More here:

Endo Pharmaceuticals Provides Regulatory Update On AVEEDâ„¢ (Testosterone Undecanoate) Injection