FDA says Cephalon's Actiq product is 'approvable'

0 Comments | Deseret News (Salt Lake City), Mar 26, 2005

FRAZER, Pa. (Dow Jones/AP) -- Cephalon Inc. Friday said the U.S. Food and Drug Administration considers the new, sugar-free formulation of pain drug Actiq "approvable."

Cephalon makes Actiq at its operations in Salt Lake City.

The biopharmaceutical company, which is based in West Chester, Pa., expects full approval of sugar-free Actiq in the third quarter. It said the sugar-free formulation will be marketed for the same indication, cancer pain, and use the same name. Studies of Actiq demonstrated that the sugar-free versions works like the currently marketed formulation, according to the company.

Cephalon noted the announcement marks the first of five FDA approvals it will be pursuing over 15 months.