FDA approves generic cancer drug amid shortage

HealthDay

WASHINGTON -- Seeking to ease potentially dangerous shortages of a key cancer drug, the Food and Drug Administration announced Monday it had fast-tracked the approval of the first generic form of one of them, Doxil (doxorubicin).

"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 of the Drug Shortage Staff at the FDA's Center for Drug Evaluation and Research.

The new generic version, made by Sun Pharma Global, will be available in 20-milligram and 50-mg vials. Like brand-name Doxil, the drug is injected intravenously by a health care professional.

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

In response to the Doxil shortage, the FDA announced in February 2012 that it would allow temporary controlled importation of Lipodox, an alternative to Doxil that is produced by Sun Pharma Global but not approved in the United States. The FDA also decided to allow the release of one lot of Janssen's Doxil made under an unapproved manufacturing process.

For the time being, the FDA said it will continue to allow the controlled importation of Lipodox. Once there is enough of Sun's generic version to meet projected demand, the agency will halt imports of any unapproved doxorubicin product.

Shortages of potentially lifesaving cancer medications have plagued the U.S. health care system for two years.