Biotech

FDA Panel Against Expansion of Cephalon's Fentora

05/06/08 - 05:36 PM EDT


A Food and Drug Administration advisory panel voted 17-to-3 Tuesday to recommend the regulatory agency not grant wider approval for Cephalon's CEPH pain treatment Fentora on the premise that such an expansion could increase the potential for drug abuse.

The drug is currently approved to treat breakthrough pain, or severe pain in cancer patients who are already taking prescription opioids. But Cephalon was seeking to expand the approved uses to include chronic pain in non-cancer patients.

The FDA isn't required to follow the recommendations of advisory panels, but it usually does.

Cephalon shares were halted from trading Tuesday ahead of the FDA panel vote.


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