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FDA Approves Generic Version of Doxil to Address Shortage

Article date: February 5, 2013

The US Food and Drug Administration (FDA) has approved the first generic version of the cancer drug Doxil (doxorubicin liposome). The drug is approved to treat Kaposi sarcoma, ovarian cancer, and multiple myeloma. It is also sometimes used for other types of cancer, such as breast cancer.

Doxorubicin liposome is currently on the FDA’s drug shortage list. The FDA’s Office of Generic Drugs is speeding up its review of generic applications to help resolve the shortages.

“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,” said Capt. Valerie Jensen, RPh, director, Drug Shortage Staff, Center for Drug Evaluation and Research, FDA, in a statement. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”

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

The generic version is marketed by Sun Pharma Global FZE (Sun).

Reviewed by: Members of the ACS Medical Content Staff


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