Tag archives: opioid drug

Centers for Medicare & Medicaid Services finalizes policies and updates to Medicare Advantage and Part D programs for 2019

On April 2, 2018, CMS released the 2019 Rate Announcement and Final Call Letter (Call Letter) and published an expansive final rule containing updates to policies for Medicare Advantage (MA) and the Medicare Part D Prescription Drug Program (Part D).  A Health Law Pulse summary of the proposed Annual Notice and Draft Call Letter may … Continue reading

FDA approves opioid drug Arymo ER for chronic pain management

On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading

FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties

On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent properties.  The FDA’s draft guidance follows its April 2015 final guidance for brand name opioids, which marked the … Continue reading