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).
opioid drug
FDA approves opioid drug Arymo ER for chronic pain management
By Yvonne Puig (US) & Mark Faccenda (US) on
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…
FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties
By Yvonne Puig (US) & Mark Faccenda (US) on
On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent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…