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FDA Okays Generic Version of Cancer Drug Doxil (Doxorubicin)

Approval expected to help solve shortage problem (Feb. 4)

The FDA has approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection; Janssen). The generic version is made by Sun Pharma Global FZE, based in Bensalem, Pa.

Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on this 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.

Generic drugs approved by the FDA have the same quality and strength as brand-name drugs, the agency claims. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Doxorubicin hydrochloride liposome injection is administered intravenously by a healthcare professional. The generic version will be available in 20-mg and 50-mg vials.

In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced that it would exercise enforcement discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection; Sun Pharma Global/Caraco Pharmaceutical Laboratories) — an alternative to Doxil that is not approved in the U.S. Enforcement discretion was also used to release one lot of Janssen’s Doxil made under an unapproved manufacturing process.

For the present time, the FDA intends to continue exercising enforcement discretion for the 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, the FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin hydrochloride liposomal product.

Sources: FDA; February 4, 2013; and FDA; February 21, 2012.

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