Cephalon Drug Partly Cleared
The Food and Drug Administration has delayed approval of an experimental cancer-pain drug from Cephalon (CEPH Quote), but the company says it expects final clearance this year, perhaps within three months.
"We are pleased with FDA's response and are working closely with the agency to secure final approval of this important new medication," said Dr. Paul Blake, an executive vice president, in a prepared statement issued Thursday.
The drug, to be sold under the brand name Fentora, won't need any additional safety or efficacy data, the company said. That may explain why Cephalon's shares gained $4.84, or 8.9%, to $59.10 in after-hours trading Thursday. ...
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