FDA Expedites Approval of Generic Version of Doxil

February 2013, Vol 4, No 2 - FDA Approvals, News & Updates


Drug shortages have hit the oncology community hard. Determined to alleviate the much-publicized drug shortage associated with doxorubicin hydrochloride liposome injection (Doxil; Janssen), the FDA expedited the approval of the first generic version of this agent, which is produced by Sun Pharma Global FZE (Sun). The FDA’s Office of Generic Drugs is using a priority review process to expedite the review of generic applications for drugs on its shortage list.

The newly FDA-approved generic formulation of doxorubicin hydrochloride liposome injection will be available in 20-mg and 50-mg vials.

To address the shortage of doxorubicin hydrochloride liposome injection, in February 2012, the FDA announced that it would exercise enforcement discretion with regard to the temporary controlled importation of an alternative to Doxil, namely, Lipodox (doxorubicin hydrochloride liposome injection), which is produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories, but is not approved by the FDA. Enforcement discretion was also used to release 1 lot of Janssen’s Doxil that is produced under an unapproved process.

The FDA announced that it would continue the importation of Lipodox, but when supplies of the approved generic formulation of doxorubicin hydrochloride liposome injection are sufficient to meet the projected US demand, the FDA would stop the use of any unapproved doxorubicin hydrochloride liposomal product in the United States. (February 4, 2013)