Drugs

FDA Approves Zohydro ER and Responds to CLAAD Citizen Petition

[10/25/2013]

FDA has approved Zohydro ER, the first extended-release, single-entity hydrocodone-containing drug product. To enhance safe and appropriate use, Zohydro ER’s labeling reflects the newly required ER/LA opioid analgesic class safety labeling changes and will be subject to the recently announced class postmarket study requirements. FDA also responded to a citizen petition (CP) concerning opioid medications and abuse-deterrence.

FDA Approves Zohydro ER and Responds to CLAAD CP

October 25, 2013

Page Last Updated: 10/01/2014
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