On Monday, the Food and Drug Administration approved a a generic version of the cancer drug Doxil, which could ease a months-long shortage of the brand name drug that has threatened the lives of thousands of patients.
Doxil is manufactured by Johnson & Johnson and was approved in 1995 to treat ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma.
The generic version of Doxil, known as doxorubicin HCI liposome injection, is manufactured by Sun Pharma Global FZE and will be available in 20 milligram and 50 milligram vials.
Doxil fell into short supply after manufacturing problems at an outside contract manufacturer suspended operations in November 2011 due to quality control problems.
In February 2012, the FDA enabled Sun to import Lipodox, the same active ingredient in Doxil, and the agency said it intends to continue allowing the importation of Lipodox until Sun has made enough generic Doxil to meet demand.
President Barack Obama made drug shortages a national priority with an executive order in October, 2011.
Comments