WASHINGTON (February 4, 2013)—The U.S. Food and Drug Administration hopes approval of the first generic version of cancer drug Doxil will help eliminate a lingering shortage resulting from manufacturing deficiencies.
Shortages of the Johnson & Johnson injectable medication, made under contract by Ben Venue Laboratories, have continued on and off for a few years and have resulted in rationing, leaving some patients with ovarian and other cancers with less effective care, and disrupting studies that are testing Doxil against possible new treatments.
The Food and Drug Administration said Monday it has approved a generic version, called doxorubicin, made by Sun Pharma Global FZE.
Last February, the FDA authorized temporary importation from India of a brand-name version, called Lipodox, also made by Sun Pharma, a subsidiary of an Indian drug maker.
Meanwhile, J&J continues to seek a contract manufacturer to replace Ben Venue.