Wider Fentora Use Could Encourage Abuse: FDA

Law360, New York (May 2, 2008, 12:00 AM EDT) -- Expanding the approved use of Cephalon Inc.'s Fentora pain reliever beyond cancer patients could lead to increased abuse and misuse of the drug, a U.S. Food and Drug Administration official said in documents released Friday.

Bob Rappaport, head of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products, wrote that prescribing Fentora for noncancer patients “may greatly increase ... the availability of the product for diversion, abuse and misuse.”

Cephalon is seeking approval to market Fentora, whose active ingredient is fentanyl, to treat sudden pain in...
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