Zohydro ER approved by USFDA The United States Food and Drug Administration (USFDA) has approved Zohydro ER (1-1ydroco-done bitartrate extended-release capsules) for the management of severe pain. Zohydro can be indicated to provide long term pain-relief, around-the-clock for patients who are unresponsive to other treatments. Zohydro ER is a Schedule II controlled substance that can be indicated as an alternative to opioid drugs. Zohydro ER is the first FDA-approved single-entity analgesic and extended-release hydrocodone analog. Zohydro ER was originally approved in 2012 with the requirement to conduct post-marketing studies. The drug is being manufactured by Zogenix Inc.