In a landmark approval on June 25th, the Food and Drug Administration (FDA) approved Epidiolex® (oral cannabidiol solution) for the treatment of seizures associated with Lennox-Gestaut Syndrome or Dravet Syndrome, in children two years of age and older. Epidiolex is the first marijuana-based drug approved for use in the United States. Two other drugs previously […] Continue
The Official Medicare Set Aside Blog And Information Resource
Endo Pharmaceuticals Voluntarily Withdraws Opana ER From the Market: What Does This Mean For Your Cases?
On July 6, 2017, Endo Pharmaceuticals issued a statement indicating it would voluntarily withdraw the opioid pain medication, Opana ER, from the market, in response to the Food and Drug Administration’s request one month earlier. As noted in our prior blog post, the FDA requested that Endo Pharmaceuticals withdraw Opana ER from the market, citing concerns of […] Continue
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
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
California Proposition 64, and Other Marijuana Legislation: Are These Legislative Actions the Gateway to Marijuana Inclusion in Medicare-Set Asides?…Not Likely.
In 1996, California became the first state to allow for medical use of marijuana. Marijuana is and remains classified as a Schedule I drug, which is defined by the United States Drug Enforcement Agency as, “substances with no currently accepted medical use and a high potential for abuse.” Schedule I drugs also include drugs, such […] Continue