The Food and Drug Administration has approved a generic formulation of doxorubicin hydrochloride liposome injection to address the current shortage of the cancer drug, the agency announced Feb. 4.
The generic formulation is manufactured by Sun Pharma Global FZE and will be available in 20-mg and 50-mg vials.
Doxil, the brand version of doxorubicin that was first approved in 1995 and is marketed by Janssen Products, is on the FDA’s Current Drug Shortages list, with the note that limited supplies are available.
To address the shortage, the FDA announced in February 2012 that it would allow Lipodox, a version of doxorubicin manufactured by Sun that was not approved in the United States, to be imported on a temporary basis to avoid interruption of the supply. The agency also allowed the one lot of the Janssen product manufactured through an unapproved process to be released for use.
"Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product," an FDA statement said.
"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," Capt. Valerie Jensen, R.Ph., director of the Drug Shortage staff at the FDA’s Center for Drug Evaluation and Research, noted in the statement. The agency is giving priority review to generic products on the drug shortage list.
Doxil is approved for treating ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.