The Official Medicare Set Aside Blog And Information Resource

FDA Requests Endo Pharmaceuticals Withdraw Opana ER From the Market

FDA, Medicare Set-Aside Blog, Opioid, Opioids on June 9, 2017 | Posted by Erin O'Neill, PA-C, JD

On June 8, 2017, the Food and Drug Administration (FDA) requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of ongoing misuse and abuse of the drug. As you will recall from our prior blog post, in March 2017, an FDA advisory committee found that the risks associated with use of Opana ER […] Continue

FDA Advisory Committee Finds Opana ER Risks Outweigh Benefits

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on March 21, 2017 | Posted by Erin O'Neill, PA-C, JD

On March 14, 2017, a Food and Drug Administration (FDA) advisory committee found that the risks associated with use of Opana ER (oxymorphone hydrochloride) outweighed the potential benefits. Opana ER is an opioid pain medication, which was first introduced in 2006 and then reintroduced in a new abuse deterrent formulation in 2012. The new formulation was designed […] Continue