FDA Approves Generic Version of Cancer Drug Doxil
On February 4, 2013 the U.S. Food and Drug Administration 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.
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.
Tags: cancer, doxil, doxorubicin, oncology