FDA approves generic Doxil

FDA approves generic Doxil
FDA approves generic Doxil

HealthDay News -- The FDA has approved a generic version of the anticancer agent Doxil, which it said should help relieve ongoing shortages of the brand-name medication.

Doxil is currently on the agency's drug shortage list. The FDA approved doxorubicin hydrochloride (HCl) liposome injection using priority review. The medication is indicated to treat a number of cancers, including leukemia, breast cancer, lung cancer, and brain cancer as a monotherapy or in combination with other treatments. It is delivered via intravenous injection.

"For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted," Valerie Jensen, RPh, director of the FDA's Drug Shortage Staff at the Center for Drug Evaluation and Research said in a press release. 

Generic Doxil will be produced by Sun Pharma Global FZE in 20 milligram and 50 milligram vials. The brand-name drug is produced by Janssen Pharmaceuticals.

The FDA noted that generics are of the same quality and strength as the original drugs, and generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

In February 2012, the FDA announced a temporary controlled importation of Lipodox (Caraco Pharmaceutical Laboratories), a Doxil alternative that is not approved in the U.S., to address the shortage. Once supplies of the generic drug are available to meet demand, the agency will stop exercising enforcement discretion for any unapproved doxorubicin HCl products, including Lipodox.

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