FDA Approval of Generic Version of Liposomal Doxorubicin Injection Is Expected to Help Resolve Shortage
The FDA has approved the first generic version of liposomal doxorubicin (Doxil), which 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, RPh, 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 [liposomal doxorubicin] were not interrupted.”
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. Liposomal doxorubicin is administered intravenously by a health-care professional. Sun’s generic will be available in 20-mg and 50-mg vials.
Effect on Drug Shortage
In February 2012, to address the shortage of liposomal doxorubicin, the FDA announced it 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. 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 liposomal doxorubicin are sufficient to meet projected demand, FDA expects to stop exercising enforcement discretion for any unapproved liposomal doxorubicin product.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
