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FDA panel opposes pure hydrocodone painkiller
WASHINGTON — Government health experts overwhelmingly voted against a stronger version of hydrocodone, the powerful painkiller that is among the most widely abused medications in the U.S.
The Food and Drug Administration’s panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting pain reliever by San Diego-based Zogenix Inc.
The FDA is not required to follow the group’s recommendation, though it often does so.
If approved, Zohydro would be the first pure hydrocodone medication approved in the U.S. Existing products combine the drug with lower-strength painkillers such as acetaminophen.
Hydrocodone is prescribed to treat pain from injuries, surgery, arthritis, migraines and a variety of other ailments.
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