The U.S. Food and Drug Administration (FDA) announced recently
that it will decide on
Endo Health Solutions
) candidate Aveed (a long-acting testosterone undecanoate
injection) by Feb 28, 2014 (target date). The U.S. regulatory
body arrived at the decision after accepting the company's reply
to the complete response letter (CRL) issued by it on Aveed in
The response of the company to the CRL satisfied the FDA, which
will review the new drug application on the candidate and come to
a decision by the assigned target date. Endo Health is looking to
get Aveed approved as a treatment for male hypogonadism.
We remind investors that the FDA had issued the CRL on Aveed as
it was apprehensive about the risks and complications which may
emanate after injecting the drug. While issuing the CRL, the U.S.
regulatory body had asked Endo Health to develop a medication
guide. Specifically, the FDA asked Endo Health to ensure that the
Risk Evaluation and Mitigation Strategy included the guide in
addition to Elements to Assure Safe Use to address the safety
issue mentioned above.
We are encouraged by the regulatory update on Aveed. The addition
of Aveed to Endo Health's product portfolio in 2014 will be a
positive for the company as some of its products are already
facing/will face generic competition.
Endo Health's second quarter 2013 revenues declined on a
year-over-year basis due to lower sales of painkiller Opana ER.
Opana ER sales were hurt by generic competition during the
We note that another painkiller at Endo Health, Lidoderm will be
facing generic competition from
) shortly. In Aug 2012, the FDA had cleared Actavis' generic
version of Lidoderm. However, Actavis' agreement with Endo Health
prohibits the former from selling the drug before Sep 15, 2013.
Endo Health carries a Zacks Rank # 3 (Hold). Companies such as
Gilead Sciences Inc.
) currently appear well placed. Both stocks sport a Zacks Rank #1
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