Maharashtra : The U.S. Food and Drug Administration today approved the 
first generic version of the cancer drug Doxil® owned by Janssen Biotech, Inc. (doxorubicin hydrochloride liposome injection). Doxorubicin HCL liposome injection is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.
Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list of supply. 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.
“The agency is committed to doing everything 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.”
Generic drugs approved by the FDA to Indian manufacturers 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.
The generic is made by Sun Pharma (Sun) and Taj Pharma Group (India). Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s and Taj’s generic version will be available in 20 milligram and 50 milligram vials for applicable markets.
In March 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced it would exercise enforcement discretion for temporary controlled importation of doxorubicin hydrochloride liposome injection generic, an alternative to Doxil® produced by Taj Phrama India under special authorised manufacturing to maximise the supply other than Janssen Biotech’s Doxil®; enforcement discretion was also used to release one lot of Janssen’s Doxil® made under an unapproved manufacturing process.
For the present time, FDA intends to continue exercising enforcement discretion for importation of generic doxorubicin hydrochloride liposome injection, as limited supplies of Doxil are available. Once supplies of Sun’s and Taj’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.
