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Thu, Nov 20, 2014

FDA approves generic form of Doxil injection

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The U.S. Food and Drug Administration has approved the first generic version of the cancer drug Doxil in an effort to combat shortages of the medicine.

Doxorubicin hydrochloride liposome injection, which is commonly used to treat patients suffering from ovarian cancer or some forms of leukemia, is currently one of the medicines listed on the national drug shortage list.

For products on the shortage list, the Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages, according to FDA officials.

“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, director of Drug Shortage Staff for the Center for Drug Evaluation and Research, an arm of the FDA.

“For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted,” she said Monday in a press release.
 
Generic drugs approved by the FDA have the same high 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, she said.

The generic is made by Sun Pharmaceutical Industries Inc., one of the largest Indian companies in the U.S. generic drug market.

Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional.

The generic form will be available in 20 milligram and 50 milligram vials.

In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, FDA officials announced the agency would exercise enforcement discretion for temporary controlled importation of Lipodox, an alternative to Doxil produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. that is not approved in the United States.

According to FDA officials, the agency intends to continue exercising enforcement discretion for importation of Lipodox while limited supplies of Doxil are available.

Once supplies of the generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, FDA officials said they expect to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product.

To find out more information, go to www.fda.gov.

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Cancer, Doxil, FDA, Health Care, Medicine
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