2013-02-05

The U.S. Food and Drug Administration (FDA) approved the first generic version Doxil (doxorubicin hydrochloride liposome injection). Doxil has been on the FDA's drug shortage list for over a year. For products on the shortage list, the FDA's Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages. The generic of doxorubicin hydrochloride liposome injection is made by Sun Pharma Global FZE (Sun). The FDA expects that the Sun generic supply will be available in approximately one month in the form of 20 milligram and 50 milligram vials.

In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announcedit 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.

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, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product. Go to the ASH drug shortage information page to find out how to access the current supply of Doxil and read more drug shortage information.

Additional information from the FDA regarding the approval of generic version doxorubicin hydrochloride liposome injection.

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