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Hoping to Ease Shortage, FDA Fast-Tracks Generic Form of Cancer Drug
Date:2/4/2013

MONDAY, Feb. 4 (HealthDay News) -- Seeking to ease potentially dangerous shortages of a key cancer drug, the U.S. Food and Drug Administration on Monday announced it had fast-tracked the approval of the first generic form of one such medication, 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," Capt. Valerie Jensen, director of the Drug Shortage Staff at the FDA's Center for Drug Evaluation and Research, said in an agency news release. "For the past year, the FDA has been working to ensure that supplies of [doxorubicin] were not interrupted."

The new generic version is made by Sun Pharma Global and will be available in 20 milligram and 50 milligram vials. Like brand-name Doxil, the injected drug is administered 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 FDA will halt imports of any unapproved doxorubicin product.

Shortages of potentially life-saving cancer medications have plagued the U.S. health care system for the past two years.

Speaking at the annual meeting of the American Society for Clinical Oncology last June, Dr. Richard
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