FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage
The U.S. Food and Drug Administration today approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).
Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list. For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate 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, R.Ph.,
director, Drug Shortage Staff, Center for Drug Evaluation and
Research, FDA. “For the past year, the FDA has been working
to ensure that supplies of doxorubicin HCl liposome injection were
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.
The generic is made by Sun Pharma Global FZE (Sun). Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s generic will be available in 20 milligram and 50 milligram vials.
In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced1 it would exercise enforcement discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection), an alternative to Doxil produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. that is not approved in the United States. Enforcement discretion was also used to release one lot of Janssen’s Doxil made under an unapproved manufacturing process.
For the present time, FDA intends to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Media Inquiries: Sandy Walsh, 301-796-4669,
Consumer Inquiries: 888-INFO-FDA
Posted: February 2013
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