The FDA has approved the first generic version of Doxil (doxorubicin hydrochloride liposome injection). Because doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list, the agency expedited the review of the generic application.

Doxil, made by Janssen Products, LP, is an anthracycline topoisomerase inhibitor. The drug is indicated for the treatment of:

  • ovarian cancer after failure of platinum-based chemotherapy
  • AIDS-related Kaposi sarcoma after failure of prior systemic chemotherapy or intolerance to such therapy
  • multiple myeloma in combination with bortezomib in patients who have received at least one prior therapy but have not previously received bortezomib.

In February 2012, the FDA announced that it would exercise enforcement discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection), an alternative to Doxil that is not approved in the United States, due to the Doxil shortage. Lipodox is produced in part by Sun Pharma Global FZE, the makers of the newly approved generic formulation of Doxil. The FDA also used enforcement discretion to release one lot of Doxil that was made under an unapproved manufacturing process. 

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Although Lipodox will continue to be imported and limited supplies of Doxil are available, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin hydrochloride liposomal product once Sun’s generic injection is available in sufficient supply to meet projected demand. The generic drug will be available in vials of 20 mg and 50 mg.