On Wednesday, the U.S. Food and Drug Administration (FDA) approved a generic version of the Doxil cancer drug, clearing the way for thousands of patients to get the treatment they need.
The generic version of Doxil is currently called "doxorubicin HCI liposome injection," and will be produced by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries.
A severe shortage of Doxil is the primary reason for the FDA's decision, as thousands of patients need the drug to survive battles with ovarian cancer, multiple myeloma, and AIDS-related Kaposi's sarcoma. Doxil's creator, Johnson & Johnson, has been unable to meet demand so far due to the fact that one of its drugmakers halted production because of quality control problems.
"The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them," said Valerie Jensen of the FDA's Center for Drug Evaluation and Research, according to Medical News Today. "For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted."
Back in 2011, President Barack Obama issued an executive order making drug shortages, as well as a speedier review process for generic drugs, a top priority for the country.
In an effort to help meet demand for Doxil, last year the FDA permitted the importation of another drug called Lipidox, developed by Sun using the same active ingredients as Doxil, despite the fact that it wasn't approved in the United States. It will continue to allow the sale and use of Lipidox until the supply of generic Doxil is enough to quell the current shortage.
"For the present time, FDA intends to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available," said the FDA. Once supplies of Sun's generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product."
Generic Doxil will be available in 20 and 50 milligram vials.
