Approval of generic Doxil is likely to help resolve shortage
Doxil (doxorubicin hydrochloride liposome injection) is currently on the FDA’s drug shortage list. However, now the FDA has approved the first generic version of the cancer drug.
The generic is made by Sun Pharma Global FZE (Sun) and will be available in 20-mg and 50-mg vials.
“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 doxorubicin HCl liposome injection were not interrupted.”
To address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced in February 2012 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 US. Enforcement discretion was also used to release 1 lot of Janssen’s Doxil made under an unapproved manufacturing process.
For the present time, limited supplies of Doxil are available, and the FDA intends to continue exercising enforcement discretion for importation of Lipodox. The FDA expects to stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product when supplies of Sun’s generic doxorubicin hydrochloride liposome injection adequately meet projected demand.
Source: FDA.