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FDA approves generic version of Doxil
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The FDA today approved the first generic version of the cancer drug doxorubicin hydrochloride liposome injection, used to treat ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma.
Currently on the FDA’s drug shortage list, doxorubicin hydrochloride liposome injection (Doxil, Janssen) has been subjected to a priority review system from the Office of Generic Drugs to accelerate the review of generic applications and alleviate shortages.
The generic version has been produced by Sun Pharma Global FZE and will be available in 20-mg and 50-mg vials.
To address the projected shortage of doxorubicin hydrochloride liposome injection, in February 2012, the FDA reported it would exercise enforcement discretion for temporary controlled importation of Lipodox, an alternative to Doxil that is produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd., but is not approved in the United States.
“The agency is committed to doing everything we can to address drug shortages so that patients can get the medicines they need when they need them,” Capt. Valerie Jensen, RPh, associate director of the drug shortage program in the FDA’s Center for Drug Evaluation and Research, said in a press release. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”
Currently, the FDA will continue to exercise enforcement discretion for importation of Lipodox while limited supplies of Doxil are available. Once supplies of the generic doxorubicin hydrochloride liposome injection are sufficient to meet the expected demand, the FDA intends to stop exercising enforcement discretion for any unapproved doxorubicin hydrochloride liposomal product.