Timeline of Opana ER June 22, 2006:FDA approves Opana ER. February 2012:Endo begins selling crush-resistant Opana ER and phasing out original Opana ER without yet raising safety concerns with FDA. May 2013:FDA denies Endo's request to declare original Opana ER unsafe and keep generics off the market. In the lawsuit, the FDA asked why Endo continued to sell original Opana ER if it thought the drug was unsafe. Asked by CNN about the safety of the generic, Impax issued a statement: "Patient safety is very important to us.

Source: CNN October 30, 2017 09:21 UTC