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FDA Approves Generic Version of Doxil; Expected to Help Resolve Shortage

doi: 10.1097/01.COT.0000428636.40337.70


The U.S. Food and Drug Administration has approved the first generic version of Doxil (doxorubicin hydrochloride liposome injection). Doxil is used to treat ovarian cancer after the failure of platinum-based chemotherapy, AIDS-related Kaposi's sarcoma, and multiple myeloma, and is currently on the FDA's drug shortage list. The generic version is manufactured by Sun Pharma Global FZE, and will be available in 20-milligram and 50-milligram vials.

“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,” Capt. Valerie Jensen, RPh, Director of the Drug Shortage Staff at the FDA's Center for Drug Evaluation and Research, said in a news release. “For the past year, the FDA has been working to ensure that supplies of doxorubicin HCl liposome injection were not interrupted.”

The agency has been using a priority review system to expedite the review of generic applications that would help alleviate shortages (OT, 8/10/12). And, in February 2012 the FDA announced it would enforce discretion for temporary controlled importation of Lipodox (doxorubicin hydrochloride liposome injection)(OT, 3/25/12), an alternative to Doxil produced by Sun and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd., which 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.

The agency noted that for the present time, it 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.

Like all generic drugs approved by the FDA, Sun's newly approved generic doxorubicin hydrochloride liposome injection has the same quality and strength as the brand-name drug. And, the generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, the FDA said.

© 2013 Lippincott Williams & Wilkins, Inc.
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