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FDA issues draft guidance for approval of generic equivalents of opioid drugs with abuse-deterrent properties

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)
By Yvonne Puig (US) & Mark Faccenda (US) on March 25, 2016

On March 24, 2016, the US Food and Drug Administration (FDA) published draft guidance to assist applicants who intend to file abbreviated new drug applications (ANDAs) for approval of generic versions of opioid drug products with abuse-deterrent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…

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