FDA Approval of Generic Version of Cancer Drug Doxil Expected to Help Resolve Shortage

The FDA approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection). Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list, in part due to ongoing manufacturing problems at Ben Venue Laboratories (see In The News, above). For products on the shortage list, the FDA’s Office of Generic Drugs uses a priority review system to expedite the review of generic applications to help alleviate shortages.


The generic is made by Sun Pharma Global FZE (Sun). Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s generic will be available in 20 milligram and 50 milligram vials.


In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced it would exercise enforcement discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection), an alternative to Doxil produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. that is not approved in the United States. Enforcement discretion was also used to release one lot of Janssen’s Doxil made under an unapproved manufacturing process.


For the present time, the FDA intends to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. 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.


See the FDA Announcement