Opana ER was first approved in 2006, and Endo Pharmaceuticals changed the original formula in 2012 to make the drug harder to abuse by snorting or injecting. However, after reviewing more information about the risks of the new Opana ER formula, the FDA believes the medication's benefits may no longer outweigh its risks and has requested the company to withdraw Opana ER from the market.
If Endo Pharamceuticals does not voluntarily withdrawal Opana ER, the FDA said it will take steps to withdrawal its approval of Opana ER, thereby forcing the drug's removal. The agency will also continue to evaluate the risks and benefits of all approved opioid analgesics.
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