On February 4, 2013, the U. S. Food and Drug Administration approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE), a generic version of DOXIL Injection (doxorubicin hydrochloride liposome; Janssen Products, L.P.) for the treatment of ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy.
FDA’s Office of Generic Drugs expedited the review of this generic application because of the drug shortage for DOXIL. DOXIL is under drug shortage because of manufacturing issues.
FDA has been exercising regulatory discretion for alternative doxorubicin hydrochloride injection products to meet patient needs. Upon approval of the generic product, FDA will stop enforcement discretion once approved product supply is sufficient to meet the patient demand. FDA will closely monitor the drug supply situation and continue to use enforcement discretion to allow importation of additional Lipodox or the release of additional lots of unapproved DOXIL until supplies of Sun Pharma’s commercially marketed lots of doxorubicin hydrochloride liposome injection in the United States are sufficient to meet the patient demand.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203263lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).