Endo Health Solutions Inc. (ENDP), 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obligation regarding the timely determination of whether the original non-tamper resistant version of Opana ER was withdrawn from the market for safety reasons.
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.
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 Allergan, Inc. (AGN).
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