The FDA announced that it has approved Doxorubicin HCl Liposome Injection, the first generic version of Janssen Biotech‘s Doxil. Doxil is an anthracycline indicated in AIDS-related Kaposi’s sarcoma refractory to combination chemotherapy, ovarian cancer refractory to platinum-based chemotherapy, and multiple myeloma, in combination with Velcade (bortezomib injection; Millenium), in patients not previously treated with Velcade and who have received at least one prior therapy.

Doxorubicin HCl Liposome Injection is currently on the FDA’s drug shortage list. In February 2012, the FDA allowed for a temporary controlled importation of Lipodox, an alternative to Doxil that was not approved in the United States. In addition, enforcement discretion was used to release one lot of Janssen’s Doxil made under an unapproved manufacturing process. Once supplies of generic Doxorubicin HCl Liposome Injection are sufficient, the FDA expects to stop exercising enforcement discretion for any unapproved Doxorubicin HCl liposomal product.

Doxorubicin HCl Liposome Injection will be made available by Sun Pharma in 20mg and 50mg vials.

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