The U.S. Food and Drug Administration today is announcing the approval of the first generic version of the chemotherapy drug Doxil, doxorubicin hydrochloride liposome injection.
This is an important market approval since the Doxil injection has been on the FDA's notorious drug shortage list for too long. Consequently, the agency is using its priority review system to speed things along and get generic versions of these shorted drugs to market as quickly and as safely as possible.
Said the FDA's Capt. Valerie Jensen, R.Ph., director, Drug Shortage Staff, Center for Drug Evaluation and Research:
"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. For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted."
This generic Doxil injection is being manufactured by Sun Pharma Global FZE (Sun) and will be available in both 20 and 50 milligran vials.
In February 2012, to address the shortage of the Doxil injection, the FDA said it would exercise enforcement discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection).
Lipodox is an alternative to Doxil also made 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, the agency will continue to exercise enforcement discretion for importation of Lipodox, and limited supplies of Doxil are available. Once supplies of Sun’s generic doxorubicin hydrochloride liposome injection can meet projected demand, the agency will likely stop exercising enforcement discretion for any unapproved doxorubicin HCl liposomal product.
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