• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail
?
-

Resources for You

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

-