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FDA has approved the first generic version of the cancer drug doxorubicin hydrochloride liposome injection (Doxil, Janssen). The generic, made by Sun Pharma Global FZE, will be available in 20 mg and 50 mg vials. The brand-name drug is currently on FDA’s drug shortage list.
To help alleviate shortages, FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications. For generic drugs to be approved by FDA, they need to have the same high quality and strength as brand-name drugs, and their manufacturing and packaging sites must pass the same quality standards.
“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 Captain 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.”
Quality control problems at the Ben Venue Laboratories, Inc. facility in Bedford, Ohio, caused the brand-name drug to fall into short supply in November 2011.
Last February, FDA allowed for the temporary, controlled importation of Lipodox, which has the same active ingredient, dosage, strength, and route of delivery as Doxil, but is not FDA approved. FDA, however, has inspected the manufacturing facility of the drug and found it to be in compliance with current good manufacturing practices. The agency will continue to allow the importation of Lipodox until the FDA-approved generic meets demand.
Doxorubicin HCl liposome injection is used to treat ovarian cancer after failure of platinum-based chemotherapy, AIDS-related Kaposi’s sarcoma, and multiple myeloma.