FDA has announced its approval the first generic version of cancer drug Doxil (doxorubicin hydrochloride liposome injection), which it hopes will help resolve shortage. This is in keeping with a promise made exactly one year ago in which the Food and Drug Administration said that “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.
“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 not interrupted.”
Jensen also stated that the FDAwould continue to continue exercising enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. However, once supplies of Sun’s generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the agency intends to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product.
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.
It should also be stressed that 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.
Anyone with questions regarding the above medication can contact the FDA directly at 888-INFO-FDA.
For a related article see http://www.examiner.com/article/fda-moves-to-avert-drug-shortage-crisis-for-children-with-cancer