Generic Version of Liposomal Doxorubicin Approved in US

Zosia Chustecka


February 04, 2013

The first generic version of doxorubicin hydrochloride liposomal injection is now available in the United States.

The generic product was approved by the US Food and Drug Administration (FDA) in a priority review aimed to help alleviate drug shortages. It is manufactured by Sun Pharma Global FZE, and will be available in 20 mg and 450 mg vials.

Doxorubicin is one of the cancer drugs that has been in short supply in the United States, both in its lyophilized power presentation (Adriamycin) and as a liposomal injection (Doxil, Janssen).

The shortage of Doxil led to stopgap measures last year, when the FDA allowed the temporary importation of Lipodox from the Indian manufacturer Sun Pharma Global. At the time, FDA commissioner Margaret A. Hamburg, MD, explained that even though Lipodox is not approved for use in the United States, the FDA can allow temporary and limited use of a foreign approved drug when there is a critical shortage that cannot be resolved quickly.

In a press release, the FDA noted that it intends to continue exercising "enforcement discretion" for the importation of Lipodox.

Limited supplies of Doxil are currently available because enforcement discretion was used to allow the release of 1 lot of the product made with an unapproved manufacturing process, according to the FDA.

"For the last year, the FDA has been working to ensure that supplies of doxorubicin hydrochloride liposomal injection were not interrupted," Capt. Valerie Jensen, RPh, from the Center for Drug Evaluation and Research at the FDA, said in the press release.

Once supplies of Sun's generic doxorubicin hydrochloride liposome injection are sufficient to meet projected demand, the FDA expects to stop exercising enforcement discretion for any unapproved product, according to the statement.