Watson's generic Fentora gets FDA approval
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.
Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.
The drug, used to treat breakthrough pain in patients with cancer, is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November, according to IMS Health. Breakthrough pain refers to flashes of pain that can’t be controlled through normal painkillers.
As the first company to file for approval of a generic version of the drug, Watson is legally entitled to 180 days’ market exclusivity in which to compete directly with the branded version.