FDA Clears Zohydro Single-Entity Hydrocodone Without Abuse Deterrence Properties
This article was originally published in The Pink Sheet Daily
Executive Summary
Advisory committee had recommended against approval before the agency imposed additional post-marketing study requirements on the extended-release/long-acting opioid class.
You may also be interested in...
Campaign Against Woodcock’s US FDA Commissioner Bid Has Begun
Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?
Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?
A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.