FDA approval of generic Doxil could help alleviate shortages

FDA’s approval of the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) could help alleviate shortages.

Doxorubicin hydrochloride liposome injection is currently on 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.

“This is welcome news from FDA to help relieve the acute shortage of a lifesaving oncology therapy,” Randy Vogenberg, PhD, RPh, cofounder, Bentelligence, Inc., a Monroe, Conn.-based healthcare market intelligence and strategy firm, told Formulary. “By using existing enforcement discretion, FDA has found a legitimate as well as safe mechanism to allow for supplies to enter the US market from registered manufacturers. This is clearly a stopgap effort, not a long-term solution.” 

The generic is made by Sun Pharma Global FZE (Sun). Doxorubicin hydrochloride liposome injection is administered intravenously by a healthcare professional. Sun’s generic will be available in 20-mg and 50-mg vials.

In February 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced 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 now, 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.