Endo Health Solutions Inc.
), a diversified healthcare company, recently suffered a setback
when its lawsuit against the US Food and Drug Administration
(FDA) regarding painkiller Opana ER was dismissed.
We remind investors that Endo Health had filed a lawsuit against
the FDA last month to protect patients from the original
non-tamper resistant formulation of Opana ER. The company,
through the lawsuit against the US regulatory body, sought a
formal determination whether the original version (non-tamper
resistant) of the drug was voluntarily removed from the market in
2012 for safety reasons (involving its abuse).
Through the lawsuit, Endo Health was also looking to secure a
verdict to prevent the FDA from clearing non-tamper resistant
generic versions of the painkiller.
Endo Health had argued in the lawsuit that the US regulatory body
did not meet its legal obligation regarding the timely
determination of whether the original non-tamper resistant
version of Opana ER was withdrawn from the market for safety
However, Endo Health's claim was dismissed as the judge did
not believe that the US regulatory body had unduly delayed making
a determination on the issue. The FDA stated that it expects to
make its determination on the matter by May next year.
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We remind investors that the new formulation of Opana ER, which
is designed to resist attempts of crushing, breaking, pulverizing
or making a powder of the product, was approved by the FDA late
last year. In June 2012, Endo Health announced the completion of
the transition to the new version.
We have a Neutral recommendation on Endo Health. The stock
carries a Zacks #3 Rank (Hold) in the short run. Health care
stocks which carry a Zacks #2 Rank (Buy), include